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Sunday, October 13, 2019

The surprising benefits of weight training

The most common misconception about weight training is that it adds bulky muscle mass, a fear of some women. While elite male lifters can—and want to—get very developed, for most people the result is simply well-toned muscles.
Other benefits are increased mobility, more support for your joints and the ability to stay self-sufficient into your late years.
As an added bonus, having more muscle can also help you with your goal. That’s because the more muscle you have, the higher your and the more calories you burn. Add a calorie cut into the mix and you’ll lose weight.
Muscle is denser than fat and it also takes up less room. That’s why you can look leaner yet actually weigh more than someone without muscle definition.
To make the most of strength training, lift heavier weights than you think you’re able to. Yes, challenge yourself, staying within safe limits. You don’t want to try to lift a weight you can barely pick up off the weight rack, but most people underestimate the amount they can handle or fail to progress to heavier weights, according to the American Council on Exercise, and that limits the effectiveness of strength training.
Keep in mind, too, that you don’t have to spend hours in the gym. All you need are 20 to 30 minutes every other day to accomplish training goals. Do one to three short sets—eight reps per set—with high weights and a mix of exercises that target all the major muscle groups.
If you’re new to , get your doctor’s OK first and work with a trainer on .

Explore further
Finding the right number of ‘reps’ when strength training

More information: The American Council on Exercise has more advice on training to lose weight.

AbbVie Stays Busy While Working to Complete Allergan Acquisition

As the $63 billion acquisition of Allergan by Chicago-based AbbVie slowly churns through the Federal Trade Commission (FTC) process, the company continues to make the news. Here’s a look.
Earlier this week, AbbVie presented new data evaluating the safety and efficacy of Skyrizi (risankizumab) at two-and-a-half years in adults with moderate to severe plaque psoriasis. AbbVie also provided additional data on Humira (adalimumab) and its JAK inhibitor upadacitinib at the 28th European Academy of Dermatology and Venereology (EADV) Congress held in Madrid, Spain.
“Leveraging more than two decades of clinical experience with Humira, AbbVie recently expanded its dermatology portfolio with the approval of Skyrizi for patients living with moderate to severe plaque psoriasis,” said Marek Honczarenko, vice president, global immunology development, AbbVie. “The new data presented at EADV will advance the knowledge around new and existing treatments for serious skin diseases, like psoriasis, as well as diseases with high levels of unmet need, such as atopic dermatitis and hidradenitis suppurativa.”
In somewhat related news, AbbVie’s newest TV ads for Skyrizi hit the air yesterday. There are three ads, one 60-second and two 30-second spots. According to TV ad tracker iSpot.tv, the spending hits around $15.6 million.
Skyrizi launched in May and the first TV ad ran in late August. The campaign is called “Nothing is Everything,” focused on the joy of clearer skin.
At least part of the idea is for Skyrizi to replace Humira, which is facing the patent cliff in the next couple years. That’s a steep hill to climb, though. Although Skyrizi brought in $48 million in its first two months of sales, Humira, even though it is beginning to slow from biosimilar competition, brought in $19.9 billion in 2018.
Skyrizi faces competition from Johnson & Johnson’s Tremfya, which was approved in 2017, and Novartis’ Cosentyx and Eli Lilly’s Taltz.
AbbVie told FiercePharma that the public needed more education about psoriasis solutions because many patients “still struggle to achieve their treatment goals due to the complex nature of the disease and variability of treatment response. Skyrizi is an important advance in the treatment of adults with moderate to severe plaque psoriasis who are seeking high levels of skin clearance that can be maintained over time.”
https://www.biospace.com/article/abbvie-stays-busy-while-working-to-complete-allergan-acquisition/

ObamaCare, not Trump, is adding to the number of uninsured Americans

On Sept. 10, the Census Bureau announced that the share of Americans without health insurance increased for the first time since 2010, the year the Affordable Care Act became law.
Defenders of ObamaCare immediately blamed President Trump for the increase in the uninsured rate. House Speaker Nancy Pelosi, never one to mince words, said Trump’s “cruel health care sabotage has left 2 million more people without health insurance.”
But a look at the actual data indicates that ObamaCare itself is driving people into the ranks of the uninsured. Sky-high premiums on the exchanges have priced millions of middle-class families out of the insurance market.

Up until recently, ObamaCare’s expansion of Medicaid had masked the thinning of the exchange pool. Medicaid enrollment swelled by more than 7.5 million between 2013, the year before expansion of the program went into effect, and 2017. So the exit of millions of middle-class families from the exchanges didn’t show up in the total uninsured numbers.
But it was happening nonetheless.
ObamaCare promised to make insurance more affordable by subsidizing premiums, and in some cases out-of-pocket costs, for families with incomes below 400 percent of the poverty line.
At the same time, it piled on benefit mandates and rate regulations that caused premiums to spiral upward. From 2013 to 2017, average individual-market premiums more than doubled. They shot up another 27 percent in 2018.

For those eligible for subsidies, these increases didn’t matter that much. Taxpayers took care of them. Those with incomes above 400 percent of poverty bore the full brunt of these premiums hikes.
So the subsidized part of the ObamaCare market remained stable. But the unsubsidized part started to collapse.

After 2015, the number of people buying insurance on the individual market who weren’t eligible for subsidies plateaued. In 2016, 10 states saw significant enrollment drops: 18 percent in Alaska, 14 percent in Minnesota. In 2017, 44 states saw sharp declines in this market; 43 had declines again last year.
Overall, 1.3 million people dropped out of the unsubsidized individual market in 2017. Last year, another 1.2 dropped out. That’s a 40 percent decline in just two years.
Another half million people who only get partial subsidies because their incomes are close to 400 percent of the poverty level left the individual market in 2018.
In other words, 1.7 million of the 1.9 million who lost insurance in 2018 came from people priced out of insurance by ObamaCare itself.
It is true that this year, average exchange premiums nationwide declined for the first time. But that average obscures the fact that several states continued to see huge jumps. In Washington, they climbed almost 14 percent. They were up 13 percent in Washington, D.C., 12.5 percent in Kentucky, and almost 9 percent in New York.
Premiums for next year are likely to follow a similar pattern. Average premiums will likely be nearly flat. But D.C. residents can expect another 9 percent increase. Premiums in Louisiana will be up almost 12 percent, and in Vermont, 11 percent. New Yorkers will face another 7 percent hike. In Louisiana, that 12 percent increase means unsubsidized families will have to cough up nearly an additional $900 in premiums.
Contrary to the talking points trotted out by ObamaCare’s defenders, average premiums declined in part because of waivers the Trump administration granted to several states, which let them use ObamaCare subsidy money more effectively. A study by the Heritage Foundation found that the median premium in six of these waiver states fell almost 11 percent this year. The median premium increased in the non-waiver states by more than 3 percent.

Five more states have put in for these waivers for next year, with the expectation that it will drive premiums down between 6 percent and 20 percent.
The waivers offer evidence that relaxing ObamaCare’s rigid rules and regulations can make insurance more affordable. And making insurance more affordable is the only sustainable way to make coverage accessible to everyone, especially those that ObamaCare drove into the ranks of the uninsured.
https://www.foxnews.com/opinion/sally-pipes-obamacare-not-trump-is-adding-to-the-number-of-uninsured-americans

Hypertension in youth: ID’ing kids that will develop it is important next step

Target Audience and Goal Statement: Pediatricians, pediatric nephrologists, pediatric cardiologists, pediatric gastroenterologists, family physicians
The goal of this systematic review and meta-analysis was to assess the prevalence of hypertension in the general pediatric population.
Question Addressed:
  • What is the prevalence of hypertension in the general pediatric population?
Study Synopsis and Perspective:
How common is high blood pressure (BP) among children and adolescents ages 19 and younger? In a systematic review and meta-analysis of 47 articles (1994-2018), researchers reported that hypertension affected 4% of children worldwide.
Compared with the 1.9% prevalence seen in children and adolescents with normal weight, Yajie Zhu, PhD, of the George Institute for Global Health at the University of Oxford in England, and colleagues found a higher prevalence of hypertension in overweight (4.99%) and obese (15.27%) children.

Action Points

  • In a systematic review and meta-analysis of 47 articles, researchers reported that hypertension affected 4% of children ages 19 and younger worldwide.
  • Note that the findings suggest that childhood hypertension is becoming more common in the general pediatric population, representing a considerable public health challenge.
While common hypertension varied when measured by different devices, a trend of increasing prevalence of childhood hypertension was seen during the study period, which spanned roughly 2 decades. Taken together, these study findings, published in JAMA Pediatrics, suggest that hypertension is relatively common in children and adolescents. Thus, pediatricians are likely to see children with hypertension in routine clinical practice.
Hypertension in adults, which can take years to develop, is known to be a major risk factor for more than heart disease. Left uncontrolled, the condition can damage the arteries, brain, kidneys, and eyes, among many other effects on the body. About half of people with untreated hypertension die of heart disease. Different lines of evidence have emerged that show that hypertension has immediate adverse effects on the heart and brain and, if present during childhood and adolescence, is linked to markers of subclinical atherosclerosis in adulthood.
From a public health perspective, reliable estimates of the prevalence of childhood hypertension could inform management of the condition and the prevention of its consequences, as well as aid in evidence-based health resource allocation and policy making, according to the group.
Because BP is so variable, hypertension definitions require systolic BP (SBP) or diastolic BP (DBP) to be persistently in the ≥95th percentile on three separate occasions, an approach recommended for children up to age 13 in the most recent American Academy of Pediatrics clinical practice guidelines. Adult guidelines for elevated BP (120-129/<80 mm Hg) and hypertension (BP >130/80 mm Hg) are used for children ≥13 years, but these measurements also need to be elevated persistently on three separate occasions.
“In children, the measurement of blood pressure is relatively complicated and unstable, so it needs to be repeated across at least three different visits to avoid false positive cases,” Zhu told MedPage Today. “Until recently, reliable estimates of childhood hypertension prevalence were lacking.” A previous meta-analysis reported the pooled prevalence of childhood hypertension at 11.2%, for example, but that analysis included studies with only one BP measurement.
Because studies included in the current review and meta-analysis were performed before new guidelines became available, the researchers used standardized definitions of hypertension based on the fourth report from the National High Blood Pressure Education Program (NHBPEP) working group for children and adolescents. Standardized definitions for some of the key BP metrics in this review were:
  • Prehypertension: an SBP and/or DBP ≥90th percentile but <95th percentile (for age, sex, and height) or ≥120/80 mm Hg
  • Hypertension: an SBP and/or DBP ≥95th percentile (for age, sex, and height) on ≥3 separate occasions
  • Stage 1 hypertension: an SBP and/or DBP ≥95th percentile (for age, sex, and height) but ≤99th percentile plus 5 mm Hg (for age, sex, and height) on ≥3 separate occasions
  • Stage 2 hypertension: an SBP and/or DBP >99th percentile plus 5 mm Hg (for age, sex, and height) on ≥3 separate occasions
To be eligible for the systematic review, studies needed to be based on a generally representative sample of children and adolescents (≤19 years of age) and provide numerical prevalence estimates of hypertension, prehypertension, stage 1 hypertension, stage 2 hypertension, or different phenotypes of hypertension (systolic hypertension, diastolic hypertension, isolated systolic hypertension, isolated diastolic hypertension, or systolic-diastolic hypertension). Only studies that repeated BP measurements on at least three separate occasions were included in the analysis.
More than two-thirds of the articles (68%) were published from 2010 onwards and the most commonly used device for BP measurement was a mercury sphygmomanometer (40.4%), followed by an oscillometric sphygmomanometer (34%). More than half the studies were conducted in low- and middle-income countries and no single study had an excessive influence on the pooled prevalence.
Pooled prevalence estimates for prehypertension and stage 2 hypertension in children ages 19 and younger were 9.67% and 0.95%, respectively. During a 15-year period (2000-2015), the prevalence of childhood hypertension across a specified age range (6 to 19 years) rose at a relative rate of 75% to 79%. A trend of hypertension with respect to age was also observed. In 2015, the prevalence of hypertension ranged from 4.32% among children age 6 years to 3.28% among those age 19, and peaked at 7.89% among children age 14.
While Zhu’s group unified the definitions of childhood hypertension and its subtypes before pooling the prevalence estimates, they acknowledged the presence of substantial heterogeneity. Uncertainties for pooled prevalence estimates were increased because of the small number of included studies for prehypertension, stage 1 hypertension, and stage 2 hypertension in children. Researchers also noted that the prevalence at the regional level was not optimal for the six World Health Organization regions covered.
Source References: JAMA Pediatrics 2019; DOI: 10.1001/jamapediatrics.2019.3310
Editorial: JAMA Pediatrics 2019; DOI: 10.1001/jamapediatrics.2019.3333
Study Highlights and Explanation of Findings:
Using 47 studies that covered urban, rural, and mixed childhood populations in many different countries, combined with a strict definition of hypertension, researchers were able to quantitate its overall prevalence as 4% in children 19 years or younger. Overweight and obese children were more likely to have hypertension than their normal-weight counterparts. Among children ages 6 to 19, the prevalence of hypertension increased from 75% to 79% from 2000 through 2015.
Researchers noted that, to the best of their knowledge, this was the first systematic review and meta-analysis to explore the global prevalence of childhood hypertension based on BP measurements on at least three separate occasions. Study strengths included comprehensive search strategies, a double review process, and stringent selection criteria, increasing the chances of generalizability by selecting studies that were conducted in the general pediatric population.
Hypertension continued to increase before the onset of puberty and during puberty, but this may not be sustained after puberty. “This finding is consistent with the clinical observation of adolescents with persistently high blood pressure, especially during periods of rapid growth in height, who can then have normal blood pressure later in adolescence and young adulthood,” wrote Stephen Daniels, MD, PhD, of the University of Colorado in Aurora, in an accompanying editorial. “It is important for adolescents with hypertension to be followed up over time to determine which adolescents will become healthier and which will develop persistent hypertension.”
Although the authors were not able to use the most recent definition of hypertension, Atul Sharma, MD, and colleagues pointed out that the use of the new clinical practice guidelines would result in elevated BP using National Health and Nutrition Examination Survey data in a separate JAMA Pediatrics study. By extension, Daniels reasoned that the prevalence of hypertension might have been increased in the current analysis.
Consistent with a prior study, the group found systolic hypertension to be common in children and adolescents. Daniels noted that elevated SBP is more closely associated with left ventricular hypertrophy than DBP. Therefore, increases in SBP might not be linked to stress and anxiety “and should be considered to be important for further workup and potential treatment.”
BP measurements should be measured at routine health maintenance visits, and when elevated BP is found, it is important for additional measurements to be made to determine whether hypertension is present, Daniels concluded.
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

VC Money Is Flowing Into Biotechs

Venture capitalists are pouring cash into U.S. biotechs at a rate set to replicate 2018’s record deal count, according to PitchBook and the National Venture Capital Association’s third-quarter Venture Monitor report.
In the first three quarters alone, VCs struck 609 biopharma deals — the majority of which were Series A or B — and contributed $11.5 billion in investments.
Notably, the average deal size shrunk from a 2018 high of $25.6 million to $21.2 million. That figure reflects growth in early stage investments but significant declines in late stage.
European biotechs have done equally well in attracting financing, according to McKinsey.
Compared to the stretch between 2005 and 2011, VC investments more than tripled to strike $2.3 billion between 2012 and 2018.

What Does The VC Landscape Look Like?

The number of VC deals this year is on track to surpass 10,000 for a total of $100 billion in financing. Companies have already raised $96.7 billion to date. Mega-deals — those exceeding $100 million — are proceeding at a record pace.
“Many in the industry anticipate an uptick in fundraising activity in the coming months as several VC firms try to close their vehicles before a possible recession hits the economy,” according to Venture Monitor.
“Further adding to fundraising optimism are realized returns that will soon be flowing back to LPs from the many massive exits we’ve seen this year. This will enable LPs to allocate capital back into the numerous VC funds seeking it.”
Between IPOs and buyouts, this year has been the most lucrative in a decade, according to Venture Monitor. With one quarter remaining, VCs have realized $200 billion in exit value — more than a quarter of which came from biopharma.

What Role Has Policy Played?

Chinese investment in U.S. biotechs is lagging, and Silicon Valley Bank expects significant reductions in Chinese inputs as the economy slows and U.S. regulators increase scrutiny of foreign money.
“Many VCs are waiting on the final rules of the CFIUS expansion to be implemented in February 2020, which will have a major impact on capital flows from foreign investors into U.S.-based startups,” according to Venture Monitor.
The NVCA said U.S. immigration policy has also affected investments: innovative scientists and prospective entrepreneurs have had difficulty entering the country. The politics of the 2020 election are expected to create a further drag on VC deals.
“Of particular note are proposals by some Democratic presidential candidates and legislators on taxing unrealized capital gains and on drug pricing, both of which could have unintended consequences for startup investing,” according to Venture Monitor.
European biotechs have seen continental slowdowns in patent procurement relative to U.S. processes.

What Does It All Mean?

The action in pharma investments isn’t necessarily indicative of a bubble, SVB analysts said. Yet they expect a near-term off-cycle amid economic slowdowns and geopolitical tension.
“Top of mind for the industry … is the pricing of these high-profile IPOs and their subsequent performance after listing,” Venture Monitor said.
“These recent listings will likely affect the sentiment around the next wave of companies looking to go public in 4Q and into the upcoming election year.”
Still, the authors consider public markets a “viable exit route” for start-ups in tech and life sciences.
https://www.benzinga.com/general/biotech/19/10/14580835/vc-money-is-flowing-into-biotechs

Marijuana legalization can help end vaping deaths by letting FDA to do its job

Cannabis is controlled as strictly as heroin, which means the federal government can’t research and regulate it for safer use.

That marijuana remains illegal at the federal level is arguably the biggest blind spot today in American public health policy. This is wrong, ill-informed and part of the reason why people are dying today from formulations of vaped cannabinoids. Where the federal government turns a blind eye, chaos reigns. This recent crisis was avoidable.
A substance that has been shown to be safer than alcohol or tobacco and with greater medicinal value than either should not be as strictly controlled as heroin.
A substance that has been shown to be safer than alcohol or tobacco and with greater medicinal value than either should not be as strictly controlled as heroin. Most of America agrees. In response, the federal government should do with marijuana what it has already done quite effectively with alcohol and tobacco: fund increased research on its health effects, stipulate regulations on safety, institute age restrictions on purchase and ensure mechanisms are in place to hold vendors accountable to a standardized set of rules across state lines.
As it currently stands, despite its legalization in 11 states and Washington, D.C., marijuana’s Schedule 1 classification means that the Food and Drug Administration (FDA) has no oversight authority on its use. It cannot evaluate something our government considers illegal, even if a growing number of states disagree and come up with their own set of nonstandardized regulations. Legalization would make us safer, as the FDA would be freed to do the job it should have been allowed to do all along: evaluate marijuana and vaping products for health and safety impacts. Former FDA commissioner Dr. Scott Gottlieb has repeatedly said as much since stepping down earlier this year.
Half measures like decriminalization miss the point entirely, conceiving of marijuana primarily as a criminal justice issue when it is foremost a public health and safety one. With decriminalization, individual users aren’t charged with a crime for possession, but distribution can still be punished. In the 38 states where it remains illegal to sell it, criminal black markets continue to thrive. Only through legalization do you significantly lessen the financial incentive for a black market and, crucially, allow for safety regulations to be put in place regarding quality and health impacts.
For those who think legalization is a pathway to more traffic accidents and increased teen usage rates, early findings from first adopters of legalization (Colorado and Washington state) argue otherwise, making clear the health benefits from legalization outweigh the downsides. The impact of federal inaction, meanwhile, has had discouraging effects, given how market forces are shaping the future of marijuana use.
The lack of regulatory oversight has been a key ingredient in creating a thriving black market of cannabis products, many of which are sold as vaping cartridges. Consider that vaping marijuana now accounts for nearly 30 percent of all legal sales of cannabis, up from just 10 percent in 2014. Within this context, it is especially alarming that the FDA has been on the sidelines, as up to now it has not evaluated any of the vaping devices (cannabis or otherwise) on the market for safety impacts. Why have an FDA at all if it is sidelined on issues so directly related to the public’s safety?
Other federal agencies, like the Alcohol and Tobacco Tax and Trade Bureau (TTB), exist to ensure compliance with a host of laws regulating advertising, product safety and voluntary recall of alcohol and tobacco products. Placing marijuana under their jurisdiction would establish further safeguards on how these potentially damaging substances can be used (for example, among states that have legalized cannabis, it is harder for teens to obtain marijuana as drug dealers are replaced by stores that require proof of age).
Separately, the Center for Tobacco Products at the FDA serves an indispensable role funding research into existing and novel forms of tobacco that then informs regulatory policies. There is no reason why a similar watchdog infrastructure cannot be established for marijuana or incorporated into the one already overseeing alcohol and tobacco.
The agencies also collect taxes on these substances, which theoretically could be used to fund substance abuse programs and promote harm reduction, similar to the approach some states have utilized when allocating revenue from state taxes on these products. Some estimates calculate that federal taxes on sales nationwide could approach nearly $130 billion over the next decade and create 1 million jobs if marijuana were legalized nationally. For comparison purposes, the government yearly nets about $20 billion from tobacco taxes and about $10 billion from alcohol levies. This system of taxation functions well because the Bureau of Alcohol, Tobacco, Firearms and Explosives, in part, oversees tax evasion regarding the sale of alcohol or tobacco.
None of the above matters, though, if we don’t have an activist FDA that is freed to do the job it was founded to do — provide leadership in protecting the public’s interest. Marijuana legalization would allow the FDA to fulfill its responsibilities on oversight while also bringing necessary scrutiny to existing vaping technology already in use. It is well past time to legalize marijuana nationally, not just decriminalize it.

Saturday, October 12, 2019

ICER says AbbVie Rinvoq for RA may be cost effective, but questions JAK value

A few days after blasting three next-generation JAK inhibitors to treat rheumatoid arthritis for offering “marginal” clinical benefits over AbbVie’s Humira, drug-cost watchdog Institute for Clinical and Economic Review (ICER) took the unusual step of pulling the report, citing the need to change its methodology. Now, the new draft report on RA drugs is out, and ICER has reversed its negative stance on one of those products: AbbVie’s Rinvoq, the company’s all-important Humira follow-up.
ICER made a few key changes in the new analysis. The reviewers changed their assumptions about how doctors treat RA patients to reflect that when patients fail one drug, they transition to a basket of targeted immune modulators—not to palliative care, as the previous model assumed. ICER also factored in a 16% loss in the efficacy of treatment whenever patients moved from a first-line to a second-line immune modulator.
Instead of analyzing the costs of the medicines over a lifetime, ICER changed the time horizon of treatment to one year. And the new assessment calculated long-term cost-effectiveness of Rinvoq based on an assumed net price that matches the current net price of Humira and that reflects the average discount of the other two JAK inhibitors.
Those changes were enough to bring the cost burden of Rinvoq below ICER’s threshold for cost-effectiveness, which is $150,000 per quality-adjusted life-year (QALY) gained. ICER determined the cost-effectiveness ratio for Rinvoq vs. Humira would be $92,000 per QALY.

ICER still had trouble assessing the other two JAK inhibitors, Pfizer’s Xeljanz and Eli Lilly and Incyte’s Olumiant, though. The agency acknowledged that all of the JAK inhibitors were superior to older drugs when it came to putting patients into remission at 12 weeks. But ICER’s reviewers cited a lack of data—specifically head-to-head data—comparing Olumiant and Xeljanz to other JAK inhibitors or to Humira.
As a result, ICER is no longer suggesting that Xeljanz’s benefits over Humira are just “marginal” as it did in the initial draft, but instead it’s lamenting the inability to fully determine the value of Rinvoq’s rivals. “This is more a limitation of the data than the model and does not inform what clinicians or policymakers would like to know: the most cost-effective choice among the three JAK inhibitors,” according to the new draft report (PDF).
AbbVie did not immediately respond to a request for comment from FiercePharma.
Eli Lilly is currently evaluating whether or not it will provide feedback to ICER on the new report, a spokesperson told FiercePharma in an email. “We remain committed to working closely with ICER to ensure the appropriate and scientifically sound assessment of Olumiant and RA medicines at large,” she said.
A spokesperson for Pfizer repeated what the company said after ICER released the first draft of the RA assessment, which is that it would provide feedback that it hopes the agency will use for the final assessment. ICER’s final draft of the report is now scheduled to be published on November 26.

If Rinvoq scores ICER’s final blessing, it could ease the marketing challenge AbbVie is facing—and make it easier for the company to pull in the $2.2 billion in annual sales that analysts are expecting for the product by 2023. Rinvoq’s success is imperative as the $20-billion-per-year Humira starts getting hammered by biosimilar competition.
Safety concerns are already complicating the sales challenge for all three makers of JAK inhibitors. When the FDA approved Rinvoq in August, the green light came with a dreaded black-box warning of an increased risk of malignancy, thrombosis and infections. Xeljanz and Olumiant bear similar warnings.
Because of the delay caused by ICER’s about-face on the original draft report, it has extended the deadline for public comments on the RA report to November 8. One of ICER’s independent appraisal groups will hold a public meeting to discuss the final assessment on December 9.
https://www.fiercepharma.com/pharma/icer-says-abbvie-s-ra-newcomer-rinvoq-may-be-cost-effective-but-still-questions-value-jak