FDA
12th September 2014

FDA Panel Votes in Favor Liraglutide for Obesity

Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met to discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection.

FDA Panel Votes in Favor Liraglutide for Obesity

Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met to discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

EMDAC voted 14 to 1 in favor of approving the drug, which is already approved to treat diabetes under the brand name Victoza. If approved by the FDA for obesity, it would be sold under the name Saxenda.

The panel concluded that liraglutide is safe and effective enough to warrant approval for use in chronically obese patients with at least one weight-related health issue.

In the primary study discussed at the meeting, half of obese patients given a daily 3 mg injection lost at least 5 percent of body weight, while 22 percent lost more than 10 percent. Patients were studied for a period of 52 weeks. Despite these positive results, one individual on the panel noted that the research did not diffuse concerns about the potential for increased cancer risks. Dr. David Kelsen of the Memorial Sloan Kettering Cancer Center, stated, “Until that information is available, there is a risk of uncertainty.”

Additionally, the drug is associated with higher resting heart rates and gallbladder-related problems.

However, the majority of the panel was in favor of the drug’s approval. “Overall, there is a benefit,” said Dr. William Hiatt of the University of Colorado School of Medicine. “If you lose weight in this manner, patients can report an improvement in their quality of life and in their physical functioning.”

In addition to the advisory committee discussion, much was heard during the open public hearing session, where panel members heard from 20 public witnesses. Two cautioned against recommendation, saying long-term cardiovascular and cancer risks have not been adequately assessed, particularly for blacks and Hispanics, who are vulnerable to obesity. Other public speakers, including some tearful obesity suffers, urged the committee to favor liraglutide in hopes of delivering an effective therapy for people who are unable to control their weight through diet and exercise.

According to the U.S. Centers for Disease Control and Prevention, more than one-third of American adults are obese. Excess weight, specifically obesity, is a leading cause of heart disease, stroke, diabetes and certain cancers. But safe and effective treatments for weight loss remain scarce.

The FDA is not obligated to agree with their advisory committees’ decisions; however, the Agency typically follows their recommendations.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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