An advisory committee to the FDA voted 14 to 1 to approve liraglutide for injection for chronic weight management in some obese patients.
An advisory committee to the FDA voted 14 to 1 on September 11 in favor of approval of liraglutide for injection for chronic weight management in some obese patients.
Committee members called for continued study of the drug’s risks in terms of cancer, cardiovascular disease, and other conditions. But it agreed in general with the agency’s assessment that the drug’s weight loss efficacy has been demonstrated across trials and patient populations, despite the fact that information about the magnitude of the treatment effect is impacted by missing data.
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The drug, sponsored by Novo Nordisk, Inc., has a proposed indication of being an adjunct to diet and exercise in adults with an initial body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more for patients with one or more weight-related co-morbidity.
FDA approved the drug in January 2010 for improving glycemic control in adult patients with type 2 diabetes, with a maximum approved dose of 1.8 mg daily. It’s marketed with the tradename Victoza.
After trials looking at several dosage levels, the sponsor submitted data in support of 3 mg daily for obesity treatment.
The public testimony period of the day-long meeting heard a number of pleas for better options for obesity treatment. But committee members voiced concerns about the lack of long-term research with the drug both in terms of efficacy and safety.
One of the public witnesses who opposed approval, Sammy Almashat, MD, MPH, of the Public Citizen group, said that, among other concerns, there is a lack of long-term evidence on cardiovascular risk and “cardiovascular risks have been consistently seen in diet drugs over time.” He noted a long-term study with Victoza will not be completed for two more years and that study will be at a lower dose and in a different patient population.
Novo Nordisk also included in its presentation a plan for a risk evaluation and mitigation strategy (REMS) that informs health professionals about the risk of medullary thyroid cancer and acute pancreatitis and about appropriate patient selection. The company says it will send a series of letters at intervals to health professionals likely to prescribe liraglutide 3 mg, will provide a website, and will assess the REMS effectiveness at one, two, three, and seven years after approval.
Background documents are available at FDA’s website.