PHARMACY

House restores $85 million in FDA sequestered user fees

BY Michael Johnsen

WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

“User fee programs are instrumental in the shared effort by FDA and the generic industry to help patients gain timely access to more affordable generic medicines and biosimilars,” stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “Restoration of previously sequestered user fees, particularly those designated in accordance with the Generic Drug User Fee Act and the Biosimilar User Fee Act, is a necessary and commendable step. Now, Agency experts can get back to business, expediting site inspections and enhancing the generic drug application and review process to ensure that savings from generic medicines are realized by patients, government, businesses and others."

User fees expected from biosimilar product applications, paid for by manufacturers under the Biosimilar User Fee Act, will give the FDA the needed resources for timely review and feedback for companies developing biosimilar products, helping to speed biosimilars to market and give consumers a more affordable alternative to brand biologic medicines, GPhA stated. 

“GPhA, its members and partners throughout the supply chain look forward to continued collaboration with the FDA. GPhA remains in full support of the application of industry-supplied user fees for safe and timely access to generics and biosimilars,” Neas said.

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Obesity drug beloranib shows promise in Prader-Willi population in Phase 2 trials

BY Michael Johnsen

CAMBRIDGE, Mass — Zafgen on Wednesday announced initial results from its Phase 2a study of beloranib, a selective inhibitor of methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome, a severe form of genetic obesity. These results showed improvements in body weight, hunger-related behaviors and body composition, including reductions in body fat content and preserved lean body mass following four weeks of treatment. 

These changes were observed despite the increased caloric intake that was a component of this trial. Known markers of beloranib response, including those associated with cardiovascular disease risk, were also improved, demonstrating that PWS patients responded to the molecular mechanism of beloranib.

“The results of this short-term, proof-of-concept study are very promising and underscore our belief that beloranib has the potential to successfully treat this severe form of obesity. To our knowledge, this study represents the largest placebo-controlled, randomized, multiple-dose trial to date for obesity in this patient population, and these results bode well for further study of beloranib in patients with this devastating condition,” said Thomas Hughes, president and CEO Zafgen. 

Similar to results seen in non-PWS obese patient populations, beloranib treatment in this study reduced body fat content by 8.1% vs. placebo in four weeks of treatment at the highest study dose of 1.8 mg, despite a 50% increased daily caloric allowance. Hunger-related behaviors improved, and a trend toward overall improvement in body weight was seen, although this did not reach statistical significance, in part due to the fact that study was not powered to demonstrate these differences. 

Key hormones, including adiponectin and leptin, also showed changes characteristic of non-PWS obese patients, demonstrating that the drug was highly active in these patients and had a similar effect to that seen in non-PWS patients. 

“These results are very exciting for the treatment of PWS, as most patients showed improvements in body weight, hunger-related behaviors and body fat content, despite the increased food intake included in the trial design,” said Jennifer Miller, associate professor of pediatric endocrinology, University of Florida, and principal investigator for the study. “PWS is a complex genetic disease that is difficult to treat and the results of this trial demonstrate that beloranib has a beneficial impact on this underserved patient population. Notably, we were encouraged by reports of fullness, a first-time occurrence for PWS patients who otherwise lack the capacity to feel sated after meals.”

“PWS patients remain severely impacted by their disease and are not treatable with other anti-obesity agents,” said Janalee Heinemann, director of research and medical affairs for the Prader-Willi Syndrome Association. “PWS represents one of the most severe forms of genetic obesity and we welcome these results, which are a significant step towards finding a treatment for those suffering from this life threatening condition.”

Beloranib, a novel obesity therapy that utilizes a unique mechanism of action, is being studied for its ability to reduce body weight and improve cardiometabolic risk factors in obese patients with and without PWS.

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Survey: Most osteoporosis patients prefer non-pill treatments

BY Alaric DeArment

SAN ANTONIO — Nearly three-quarters of osteoporosis patients prefer to take their medication in a form other than an oral solid, according to a new survey.

The survey was sponsored by drug maker Mission Pharmacal and conducted by Inspire, a company that develops health and wellness communities for patients and caregivers, using patients drawn from the online support community of the National Osteoporosis Foundation. It found that 74% prefer their medication in a form other than a capsule or tablet. Mission Pharmacal is the manufacturer of the drug Binosto, a water-dissolvable tablet that delivers the drug alendronate sodium as a strawberry-flavored fizzy solution.

The company said the purpose of the survey was to raise awareness of osteoporosis and encourage people to talk to their doctors about treatment options, and it showed that most patients with the condition want a choice in the medication they take.

"The results of this survey show that patients are interested in options," said Robert Recker, director of the Osteoporosis Research Center at Creighton University in Omaha, Neb. "We take medication compliance very seriously because we know it can result in fewer fractures with osteoporosis."

 

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