Teva Migraine Treatment Approved by the FDA Ready to Roll in 2 Weeks

The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries’Ajovy (fremanezumab) to prevent migraine on Friday, September 16.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, director, Jefferson Headache Center at Thomas Jefferson University Hospital and lead investigator of the Phase III clinical trial program for the drug, in a statement. “About 40 percent of people living with migraines may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”

The drug is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) ligand.

Despite the approval, Teva is running behind in this area. In May, the FDA approved Amgen andNovartis’ Aimovig (erenumab-aooe) for the prevention of migraines in adults. It was the first-and-only FDA-approved treatment designed to prevent migraines by blocking the calcitonin gene-related peptide receptor (CGRP-R). Aimovig 70 mg is self-administered once a monthly by way of Amgen’s SureClick autoinjector.

Ajovy may, however, have an advantage. It’s also injectable, but it only requires injections once every three months. However, in June, the company halted a Phase III clinical trial of the drug for prevention of chronic cluster headaches. They indicated at the time that it wasn’t likely to hit the primary goal of reducing the average number of cluster headaches in the 12-week treatment period. However, it proved to be effective in preventing migraine.

Eli Lilly is also developing a migraine drug in the same class, with an FDA action date of September 27.

Teva indicates they are ready to go with the drug and expect it to hit the market within the next two weeks. The U.S. Wholesale Acquisition Cost (WAC) for the drug is $575 per monthly dose and $1,725 for a quarterly dose. It will be available through retail and specialty pharmacies. Teva has also stated that commercially insured patients may pay as little as $0 until the offer expires. For patients looking for financial support, the company offers Teva Shared Solutions, with more details available at AJOVY.com.

Brendan O’Grady, head of Teva’s North America commercial operations, told Reuters, “We felt that $575 was an appropriate price.” It’s also the price Amgen and Novartis are charging for Aimovig.

A consensus of analyst projections compiled by Bloomberg estimates sales of around $500 million by 2022. Bloomberg writes, “Ajovy’s launch could help Teva, the world’s largest generic drugmaker, eventually replacing declining sales of Copaxone, its aging star product. Investors have tracked the new drug’s trajectory as one of the few channels of growth for the debt-laden pharma giant. Chief Executive Officer Kare Schultz embarked on a massive cost-cutting plan last year and placed debt repayment as his top priority, in effect shelving designs to increase sales in the coming two years.”

Part of Schultz’s cost-cutting measures have included laying off more than a quarter of Teva’s workforce and closing or selling 10 of its factories. In August, the company indicated its net debt had dropped from $35 billion to $28.4 billion.

In a statement, Schultz said, “This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system. The approval of Ajovy helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders — patients, employees and shareholders.”

https://www.biospace.com/article/fda-action-alert-migraine-treatment-approved-by-the-fda-ready-to-roll-in-2-weeks/

BeiGene initiated at Guggenheim

BeiGene initiated with a Buy at Guggenheim. Target $214.
https://thefly.com/landingPageNews.php?id=2791649

Array BioPharma, Deciphera, ImmunoGen initiated at Guggenheim

Guggenheim calls Array, Deciphera, ImmunoGen top biotech picks. Guggenheim initiated coverage of the biotechnology sector, initiating and assuming coverage of 17 biotechnology stocks, and saying it is bullish on the sector longer term and expects continued growth. The firm’s coverage focuses on the oncology therapeutic category, with Guggenheim calling Array Biopharma (ARRY), Deciphera Pharmaceuticals (DCPH), and ImmunoGen (IMGN), which all have key catalysts coming in the first half or 2019, its top picks.
https://thefly.com/landingPageNews.php?id=2791671

Janssen INVOKANA, VOKANAMET Euro label to include positive cardio data

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted approval to update the INVOKANA(canagliflozin) and VOKANAMET (canagliflozin and metformin) labelling to include changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.

The decision means that the product information now includes data on the reduction in major adverse cardiovascular (CV) events (cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke) in patients with type 2 diabetes mellitus (T2DM) who had either a history of CV disease or at least two CV risk factors, in addition to the existing study results on improving glycemic control.

‘We hope this approval will not only provide clinicians with a more detailed overview of canagliflozin but also help them when making informed treatment decisions which are most appropriate for their patients. Type 2 diabetes mellitus is one of the most common forms of diabetes and accounts for the majority of diabetes cases worldwide so it is extremely important that we continue improving outcomes for these patients,’ said Dr. Jose Antonio Buron, Vice-President Medical Affairs EMEA, Janssen-Cilag Farmaceutica, Lda.

The EC’s decision follows a recommendation from the Committee for Medical Products for Human Use (CHMP) that was based on data from the CANVAS Program, the largest completed CV outcomes trial to date for an SGLT2 inhibitor.[1] The study, which included over 10,000 patients started in 2009, met its primary endpoint and showed canagliflozin significantly reduced the combined risk of CV death, myocardial infarction and non-fatal stroke, versus placebo in adult patients with T2DM who had either a history of CV disease or at least two CV risk factors.1

Canagliflozin also significantly lowered the risk of hospitalisation for heart failure and demonstrated improved renal outcomes.1 Adverse events reported in the CANVAS Program were generally consistent with the known safety profile of canagliflozin.1 However, the study found that, in patients with T2DM who had established CV disease or at least two risk factors for CV disease, canagliflozin was associated with an approximately 2-fold increased risk of lower limb amputation with the rate of amputation over standard of care being 0.63/100 patient years for canagliflozin versus 0.34/100 patient years for placebo which corresponds to an additional risk of 0.29/100 patient years.1The risk of amputations across the class has previously been investigated by the EMA, and this is reflected in a warning in the labelling of SGLT2 inhibitors.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-European-Commission-expands-labelling-for-Janssen-s-INVOKANA-and-VOKANAMET-to-in-27272242/

U.S. review of CVS deal for Aetna may end soon

The U.S. Justice Department’s antitrust review of CVS Health Corp’s planned purchase of Aetna Inc may conclude soon, a source familiar with the review said on Monday.

That said, arranging divestitures needed to resolve antitrust concerns in the proposed transaction takes time and it is not clear that possible approval will come in September, said the source.

The $69 billion deal was announced in December.

https://www.marketscreener.com/CVS-HEALTH-CORPORATION-12230/news/CVS-Health-U-S-review-of-CVS-deal-for-Aetna-may-end-soon-27273301/

‘No Documented Reason’ for 1 in 3 Outpatient Opioid Prescriptions

The United States is in the grip of an epidemic of opioid painkiller addiction. But now, research shows that in nearly a third of cases there’s no medical reason documented for opioids prescribed in an outpatient setting.

The findings show the need for stricter rules on recording patients’ needs for the highly addictive drugs, the research team said.

When medical records fail to spell out the reason a patient got an opioid painkiller, this “undermines our efforts to understand physician prescribing patterns and curtails our ability to stem overprescribing,” study lead author Dr. Tisamarie Sherry said in a Harvard Medical School news release. She’s an instructor in medicine at Harvard and an associate physician at Brigham and Women’s Hospital in Boston.

One addiction specialist said real solutions to overprescribing are needed.

“Despite numerous policy changes, recent analyses suggest national opioid prescribing rates have not meaningfully decreased,” noted Dr. Harshal Kirane, who directs addiction services at Staten Island University Hospital in New York City.

Kirane described the rate of poorly documented prescribing seen in the study as “alarming,” suggesting that “lax prescribing practices remain widespread.”

There were more than 63,600 drug overdose deaths in the United States in 2016, according to the U.S. Centers for Disease Control and Prevention. About two-thirds involved an opioid. On average, 115 Americans die every day from an opioid overdose.

In the new study, Sherry’s group tracked data on opioid prescriptions given during nearly 809 million doctor’s office visits nationwide between 2006 and 2015.

Of those prescriptions, just over 5 percent were for cancer-related pain and 66.4 percent were for treating non-cancer pain.

For the other 28.5 percent, there was no record of pain or a pain-related condition, the researchers said.

Of the prescriptions for non-cancer pain, the most common conditions included back pain, diabetes and arthritis.

Of the prescriptions with no record of pain, the most common conditions were high blood pressure, high cholesterol and opioid addiction (2.2 percent).

Prescriptions with no record of pain were more common in visits where opioid prescriptions were being renewed (30.5 percent) than in visits that involved new prescriptions (22.7 percent), the study found.

The researchers said there’s been a sharp rise in opioid prescriptions in the past 20 years — an increase that exceeds actual rates of pain in the population. It’s possible that too often, opioids are being prescribed for conditions that don’t warrant treatment with the drugs, Sherry and colleagues said.

Dr. Robert Glatter is an emergency physician at Lenox Hill Hospital in New York City. He’s seen the ravages of opioid addiction firsthand, and believes many cases were avoidable.

When patients come to a doctor seeking pain relief, “we have to ask ourselves why we are prescribing an opioid in the first place?” Glatter said.

“Are there other alternatives that may work, but also help reduce risks for side effects, dependence, abuse or misuse?” he said.

And even if an initial prescription of an opioid was justified, that “does not automatically justify a refill of that medication for future and ongoing care,” Glatter said.

He said even though the paperwork might be time-consuming, it’s important for physicians to record their rationale for giving someone an opioid.

Non-opioid medications and other alternative approaches must be considered, Glatter said. All of this “requires creativity and taking time to ‘think outside the box,’ ” he said. “We owe it to our patients and their families.”

The study was published Sept. 10 in Annals of Internal Medicine.

More information

The U.S. National Institute on Drug Abuse has more about prescription opioids.

SOURCES: Harshal Kirane, M.D., director, addiction services, Staten Island University Hospital, New York City; Robert Glatter, M.D., emergency physician, Lenox Hill Hospital, New York City; Harvard Medical School, news release, Sept. 10, 2018

https://consumer.healthday.com/mental-health-information-25/addiction-news-6/no-documented-reason-for-1-in-3-outpatient-opioid-rxs-study-737534.html

Chronic pain surgery called too risky, costly

With high costs, risks of adverse events, and scant evidence of effectiveness, surgery for chronic pain is a prime example of overutilization of healthcare services.

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KEY TAKEAWAYS

More than 100 million Americans suffer with chronic pain.

Annual costs associated with chronic pain range as high as $635 billion.

Research shows the risk of adverse events is significantly higher for invasive procedures (12%) than sham procedures (4%).

There is inadequate evidence to justify surgical procedures to treat chronic pain, recent research shows.

“Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain,” researchers reported this month in the journal Pain Medicine.

Chronic pain is a widespread and costly condition in the United States, affecting more than 100 million people and costing as much as $635 billion annually.

The Pain Medicine research features a review of 25 clinical trials involving 2,000 patients with conditions including lower back pain, arthritis, angina, abdominal pain, and endometriosis.

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The researchers compared outcomes for invasive procedures and sham procedures. In a sham procedure, the patient goes through the rituals of a surgical procedure such as preparations and set up, anesthesia if needed, and tissue penetration. However, the tissue is not manipulated in a way that is thought to correct the underlying problem, and the patient is closed up or the instrument withdrawn.

For adverse events, there was a significantly higher risk for invasive procedures (12%) than sham procedures (4%).

The risks associated with surgery for chronic pain are too high and more clinical trials should be conducted, the researchers wrote.

“The risks of surgical and invasive procedures are not minor and appear to be higher with real compared with sham procedures. Risks in both groups include anesthesia, permanent injury to the body, psychologic stress, and time, cost, and productivity losses. Without more rigorous examination, large numbers of patients are exposed to risky and possibly unnecessary procedures.”

The lead author of the research, Wayne Jonas, MD, executive director of Samueli Integrative Health Programs at H&S Ventures in Alexandria, Virginia, says physicians and chronic pain patients should consider surgery carefully.

“Right now, the scientific evidence does not justify doing these procedures for chronic pain. However, patients and circumstances vary, and physicians and patients need to decide individually what’s appropriate for any particular patient. Taking this evidence and discussing it with the patient in shared decision-making is the best approach,” Jonas told HealthLeaders last week.

ALTERNATIVES TO SURGERY

Surgery for chronic pain is a prime example of overutilizationof healthcare services and poor care coordination, Jonas says.

“It takes a multidisciplinary team of healthcare professionals at its center to help manage chronic pain. Yet one of the things the U.S. healthcare system as a whole systematically fails at is fostering coordinated care. Most care is piecemeal with little communication among providers. So, people with chronic pain are left to jump from provider to provider, often undergoing unnecessary, costly, duplicative procedures, and taking ineffective drugs—with ultimately little relief.”

There are several options for treating chronic pain that do not involve invasive procedures or addictive medications such as opioids, he says.

“The American College of Physicians, the Centers for Disease Control and Prevention, the National Institutes of Health, and many other national bodies have recommended nonpharmacological approaches for the treatment of chronic pain. These include acupuncture, yoga, massage, and other such approaches. In addition, behavioral medicine has been demonstrated for many decades to be effective for chronic pain.”

https://www.healthleadersmedia.com/clinical-care/chronic-pain-surgery-called-too-risky-and-too-costly