FDA Action Alert, Week of Nov. 5

Although there is some slowdown as the U.S. Food and Drug Administration (FDA) moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.

EyePoint Pharmaceuticals’ Durasert for Posterior Segment Uveitis

EyePoint Pharmaceuticals (formerly named pSivida), located in Watertown, Mass., has a target action date of November 5 for its New Drug Application (NDA) for Durasert for three-year treatment for posterior segment uveitis. Posterior segment uveitis is a chronic, non-infectious inflammatory illness that affects the posterior segment of the eye. It often also involves the retina and is a leading cause of blindness in the developed and developing countries. Current treatment is systemic steroids, but in time patients develop serious side effects.

“The FDA’s acceptance for review of our Durasert NDA submission is a major milestone for pSivida and we look forward to continuing to work with the FDA as they review our application,” said Nancy Lurker, EyePoint’s president and chief executive officer, in a March statement. “Given the high unmet medical need, we believe that Durasert, if approved, has the potential to become an important new treatment option for the thousands of patients suffering from posterior segment uveitis, the third leading cause of blindness.”

Durasert is a miniaturized, injectable, sustained-release drug delivery system that can last up to three years. It can be administered in the office setting via a needle as small as 25-gauge. So far, four products using the technology have received FDA approval: Yutiq (fluocinolone acetonide intravitreal implant); Iluvien (fluocinolone acetonide intravitreal implant), licensed to Alimera Sciences; Retisert (fluocinolone acetonide intravitral implant); and Vitrasert (ganciclovir), licensed to Bausch & Lomb.

Merck’s BLA for Keytruda in Advanced Hepatocellular Carcinoma

Merck & Company’s supplemental Biologics License Application (sBLA) for Keytruda for previously treated patients with advanced hepatocellular carcinoma (HCC) has a target action date of November 9. Keytruda is Merck’s dominant anti-PD-1 therapy. The application for this indication is based on data from the Phase II KEYNOTE-224 clinical trial, which was presented at the 2018 American Society of Clinical Oncology Annual Meeting in June and published in The Lancet Oncology.

“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma, which is the most common type of liver cancer,” said Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories, in a July statement. “The data supporting our application provide a clear rationale for the advancement of the Keytruda clinical program for hepatocellular carcinoma, and we are grateful for the opportunity to work with the FDA to potentially bring Keytruda to patients living with this difficult-to-treat cancer.”

On October 31, the FDA granted Merck’s Keytruda approval as a first-line treatment for patients with metastatic squamous non-small cell lung cancer (NSCLC). In fact, it seems as if the agency is approving Keytruda for something nearly every week. And if the FDA isn’t, the European Medicines Agency (EMA) probably is. The drug brought in more than $3.8 billion for the company in 2017.

Keytruda is a human programmed death receptor-1-blocking antibody. It is indicated for melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

It was first approved for use in the U.S. on June 30, 2014.

https://www.biospace.com/article/fda-action-alert-eyepoint-pharma-and-merck/

For older adults, does eating enough protein help delay disability?

To live successfully and independently, older adults need to be able to manage two different levels of life skills: basic daily care and basic housekeeping activities.

Basic daily care includes feeding yourself, bathing, dressing, and going to the toilet on your own.

You also need to handle basic housekeeping activities, such as managing your finances and having the mobility to shop and participate in social activities.

If you or someone you care for has trouble performing these two types of life skills, this may bring on problems that can reduce quality of life and independence. People 85-years-old and older form the fastest-growing age group in our society and are at higher risk for becoming less able to perform these life skills. For this reason, researchers are seeking ways to help older adults stay independent for longer. Recently, a research team focused their attention on learning whether eating more protein could contribute to helping people maintain independence. Their study was published in the Journal of the American Geriatrics Society.

Protein is known to slow the loss of muscle mass. Having enough muscle mass can help preserve the ability to perform daily activities and prevent disability. Older adults tend to have a lower protein intake than younger adults due to poorer health, reduced physical activity, and changes in the mouth and teeth.

To learn more about protein intake and disability in older adults, the research team used data from the Newcastle 85+ Study conducted in the United Kingdom (UK). This study’s researchers approached all people turning 85 in 2006 in two cities in the UK for participation. At the beginning of the study in 2006-2007, there were 722 participants, 60 percent of whom were women. The participants provided researchers with information about what they ate every day, their body weight and height measurements, their overall health assessment (including any level of disability), and their medical records.

The researchers learned that more than one-quarter (28 percent) of very old adults in North-East England had protein intakes below the recommended dietary allowance. The researchers noted that older adults who have more chronic health conditions may also have different protein requirements. To learn more about the health benefits of adequate protein intake in older adults, the researchers examined the impact of protein intake on the increase of disability over five years.

The researchers’ theory was that eating more protein would be associated with slower disability development in very old adults, depending on their muscle mass and muscle strength.

As it turned out, they were correct. Participants who ate more protein at the beginning of the study were less likely to become disabled when compared to people who ate less protein.

Dr. Nuno Mendonca, the principal author of the study, said: “Our findings support current thinking about increasing the recommended daily intake of protein to maintain active and healthy aging.” Older adults should aim to eat about 1.0 to 1.2 grams of protein for every 2.2 pounds of body weight. For example, for a person who weighs 160 pounds, that would be about 58 grams of protein a day (a 3.5-ounce serving of chicken contains about 31 grams of protein). Find your recommended daily protein intake — and other important nutritional needs — by using this calculator.

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Story Source:

Materials provided by American Geriatrics Society. Note: Content may be edited for style and length.

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Journal Reference:

1. Nuno Mendonça, Antoneta Granic, Tom R. Hill, Mario Siervo, John C. Mathers, Andrew Kingston, Carol Jagger. Protein Intake and Disability Trajectories in Very Old Adults: The Newcastle 85 Study. Journal of the American Geriatrics Society, 2018; DOI: 10.1111/jgs.15592

https://www.sciencedaily.com/releases/2018/11/181102105941.htm

Benefits, Risks To Online Patient Support Groups: Oncology Journal

Online cancer communities allow groups of people with expressed interest in cancer to communicate using a website, instant messaging, or email. Forming online communities generates several patient benefits, according to a recent research article in Journal of Oncology Practice.

“Online communities can provide a measure of emotional support that may be comforting to patients and caregivers. Connecting with someone who has undergone a similar experience can be helpful by providing a personal perspective in addition to valuable information,” the researchers wrote.

They found additional benefits included connecting individuals with rare diseases to patients who share the diagnosis, low or no cost to patients for the community platform, and privacy and anonymity protection.

Building and maintaining online communities includes planning, platform selection, proactive management of user posts, and caregiver engagement.

Fostering Online Communities

There are essential ingredients to grow an online community for patients, said Lidia Schapira, MD, the corresponding author for the Journal of Oncology Practice study.

“Important steps in launching an online community include defining its goals and deciding which platform on which to host it. Since the initial weeks and months help establish the culture and norms for the community, proactive management during this time is especially important. It is also important to involve and acknowledge needs of caregivers and to anticipate the need for revisions as the community evolves,” she said.

With a cultural foundation in place, an online community can offer different levels of communication:

• Individual users post questions, answer questions, and create content in a shared space
• Users have the option to lurk — i.e., read postings in the community without communicating
• Multiple users can influence content

There are several approaches to maintaining an online community, Schapira said.

“Important ingredients for maintaining an online community include: community managers, a regular influx of new members, and mechanisms for members to provide feedback on how to improve the community. What we learned from our interviews and research is that, in addition to motivation, it takes a concerted and disciplined effort to maintain a community,” she said.

Online Community Pitfalls

There are several risks associated with online communities.

“Oncologists’ most pressing concern is the exposure to misinformation. Scientific information may be misunderstood, and patients often report that comments they read on the Web are not only unhelpful but also scientifically flawed,” Schapira and her co-author wrote, adding that online communities can also pose social risks.

“Other risks include the possibility of becoming so addicted to or reliant on Internet-based relationships as to become more socially isolated. A possible risk may also come from oversharing or sharing personal details that may compromise the patient’s own privacy and that of family members and members of the care team.”

The helper therapy principle also bears risk in online communities. The principle applies when patients provide support to others who are facing similar circumstances.

“Although some have suggested that serving this role can be therapeutic, there is concern that occupying the role of the helper could also limit patients from being able to express their needs openly, thereby preventing them from attaining full benefit of the support group,” the researchers wrote.

Clinical Effect Unclear

The impact of online communities on clinical outcomes is unknown, Schapira said.

“Our discovery work taught us that we need novel research methods to analyze how and if participating in an online community impacts measurable health outcomes — these could be measures of self-efficacy, coping, managing symptoms of illness or side effects of cancer therapy,” she said.

Caregivers are another area requiring more online community research, Schapira said.

“There is also a need to study the impact on family caregivers’ ability to handle their increasingly important roles in providing support and advice and managing complex decision-making.”

This report is brought to you by HealthLeaders Media.

LAST UPDATED 11.02.2018

• Primary Source

  Journal of Oncology Practice

  Source Reference: Gupta T, Schapira L “Online Communities as Sources of Peer Support for People Living With Cancer: A Commentary” J Onc Pract 2018 DOI: 10.1200/JOP.18.00261.

https://www.medpagetoday.com/hematologyoncology/othercancers/76094

Alzheimer’s biotech Alzheon decreases proposed IPO deal size

Alzheon, a Phase 3 biotech developing small molecule therapies for Alzheimer’s disease, lowered the proposed deal size for its upcoming IPO on Friday.

The Framingham, MA-based company now plans to raise $30 million by offering 6 million shares at a price range of $4 to $6. The company had previously filed to offer 2.5 million shares at a range of $13 to $15. At the midpoint of the revised range, Alzheon will raise 14% less in proceeds than previously anticipated.

Alzheon was founded in 2013 and plans to list on the Nasdaq under the symbol ALZH. ThinkEquity and H.C. Wainwright are the joint bookrunners on the deal.

Relevant Profile: ALZH

https://www.renaissancecapital.com/IPO-Center/News/60642/Alzheimers-biotech-Alzheon-decreases-proposed-IPO-deal-size

Becoming a Baby Bear: How We Can Do A Better Job Of Reaching Our Goals

As this video of a baby bear from @ziyatong graphically depicts, there is a lot to be said for motivation as a path toward our goals.  When the situation is urgent and the endpoint remains in front of us, we can summon great drive to achieve the seemingly impossible, just like that baby bear.

The problem is that situations are not always *so* urgent and goals are not always so clearly visible.  We make resolutions and goals in one state of mind only to find that urgency waning when our attention is taken elsewhere.  That is why motivation is necessary to reach challenging goals, but not sufficient.

In the latest Forbes article, I outline two key factors that help us reach our goals.  In that article, I link excellent research resources that highlight ways in which we can move from the daily leading of our lives to becoming actual leaders of our lives.

A key, per Zig Ziglar’s quote above, is turning motivation into a habit.  That is, we create routines–processes–for tapping into the values and visions that animate our lives.  This is why a religious person will start their day with prayer.  The morning prayer, at one level, is a habit.  At another level, it is a way of connecting with what is meaningful and motivating.

When we have habits that tap into motivation, suddenly our goals become urgent and visible–and we can be like that baby bear.  It’s not enough to wake up our bodies in the morning; we also have to awaken spirit.  Without the habit of motivation, goals become little more than wishes…entries in our trading journals that show good intentions, but little more.

What is *your* process for becoming a baby bear?

http://traderfeed.blogspot.com/2018/11/becoming-baby-bear-how-we-can-do-better.html

Online program helps prevent teen depression

Screengrab example of the web-based CATCH-IT depression prevention intervention. Credit: UIC/Monika Marko and TJ Crawford

Although up to 20 percent of adolescents experience a depressive episode each year, the medical community has struggled to implement programs that effectively prevent depression.

Researchers at the University of Illinois at Chicago have worked to fill this gap in pediatric primary care by conducting clinical trials to evaluate and compare interventions. A new study published in JAMA Network Open highlights the positive effect of one web-based intervention, called CATCH-IT, on preventing depressive episodes among adolescents most at risk.

The multicenter, randomized clinical trial compared the CATCH-IT intervention—which consisted of depression-specific online learning modules, motivational interviews and coaching—with a control intervention. The control intervention consisted of general health education and was similarly delivered through online learning modules.

More than 350 adolescents ages 13 to 18 from a mix of rural and urban areas were enrolled in the trial. Participants had either a history of depression or depressive symptoms, which were measured and assigned a score during screening. The researchers followed the participants for two years and tracked depressive episodes.

While depressive symptoms were reduced across all participants, they found no difference between the groups, except for among higher-risk adolescents whose depressive symptoms scored high on baseline screening. Among this group, individuals who participated in the CATCH-IT intervention demonstrated greater benefit, achieving as much as 80 percent risk reduction for experiencing a depressive episode.

“This study tells us that the online intervention works best for teens who are experiencing worse symptoms,” said Dr. Benjamin Van Voorhees, the principal investigator. “We hypothesized that there would be a benefit across all participants, but it is perhaps even more telling to see such a significant risk reduction among a smaller group of high-risk adolescents.”

Van Voorhees, professor and head of pediatrics at the UIC College of Medicine, said that the results indicate to physicians and researchers that “when it comes to first-line programs for depression prevention, scalable solutions may need to be targeted to patients based on symptom severity, not prior history alone.

“We need to move depression care away from reactive treatments to widespread prevention, but to be successful we need more research on which interventions work, and for what patients, in primary care settings,” Van Voorhees said. “This is the first study to test a depression prevention intervention in a primary care setting—primary care providers are likely to be the first people parents ask for help and they are also often among the first to identify worrisome trends towards depression.”

“Often primary care physicians recognize sub-threshold depressive symptoms in their adolescent patients but do not have an appropriate way to respond,” said Tracy Gladstone, co-principal investigator and associate director and senior research scientist at the Wellesley Centers for Women at Wellesley College. “Our hope is that this intervention can serve as a first-line, evidence-based response to support symptomatic teens before they develop a full-blown depressive illness.”

For parents, Van Voorhees said the results should reinforce the need for action if teens display early signs of depression.

“If their teen’s behavior is changing, parents should not wait to seek help,” he said. “While this study showed that high-risk teens benefited most from the online intervention, it also showed that participation in the study, regardless of which group, helped reduce depression symptoms. We know that simply engaging in physical activity, practicing intentional positivity and engaging with family, friends and activities can help teens ward off major depressive episodes.”

CATCH-IT is an acronym for Competent Adulthood Transition with Cognitive behavioral Humanistic and Interpersonal Training and was designed to teach coping skills to teenagers and young adults. The intervention included 20 modules, 15 of which were for adolescents. The remaining five were for parents. The information in the modules was based primarily on previously validated educational materials on coping with depression and behavioral and interpersonal psychotherapy methods. Example modules included lessons on ways to escape negative thoughts, identifying triggers and habitual responses, and how to solve problems in stressful situations.

The control group intervention consisted of 14 modules for adolescents and four modules for parents that provided instruction on general health topics, such as good nutrition, sleep, exercise and safety habits.

Trial sites included Wellesley College, NorthShore University HealthSystem, Harvard Vanguard, Advocate Children’s Hospital, Access, Franciscan Alliance, and UI Health Mile Square Health Centers.

More information: JAMA Network Open (2018). DOI: 10.1001/jamanetworkopen.2018.4278 , https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2712184

https://medicalxpress.com/news/2018-11-online-teen-depression.html

GEICO Asks Drivers to Wake Up to the Risks of Drowsy Driving

As the clocks fall back, the amount of daylight starts to dwindle. While drivers spend more time in the dark over the fall and winter months, GEICO has the following reminders to help them avoid becoming drowsy behind the wheel.

GEICO graphic with reminders about the dangers of driving while drowsy (Graphic: GEICO)

• Catch enough Z’s: It’s important for adults to get eight hours of sleep a night according to the National Institutes of Health. Getting behind the wheel while sleep deprived makes it harder for drivers to focus, and can lead to difficulties reacting to hazards in the road and changes in traffic.
• Limit driving during peak sleepiness periods:Drowsiness is more likely to set in during the hours between midnight and 6 a.m. according to the National Highway Traffic Safety Administration (NHTSA). If drivers need to head out at this time, they should remain vigilant for signs of drowsiness such as crossing lines or hitting rumble strips.
• Check medications: Both prescription and over-the-counter medications could cause drowsiness as a side effect. NHTSA recommends using public transportation when possible if you take medicine that causes noticeable drowsiness.
• Take a break: If your eyes start to get heavy in the driver’s seat, avoid trying to fight through it. Pull off to a safe spot such as a rest stop and nap for 20 minutes, or switch drivers if you have a passenger with you.
• Recharge with a beverage: Sipping on coffee or an energy drink can provide a quick fix to feeling drowsy; however, it may only deliver temporary relief.

For more safe driving tips, visit GEICO’s Safe Driving Resources page.

https://www.biospace.com/article/releases/geico-asks-drivers-to-wake-up-to-the-risks-of-drowsy-driving/