Fuji Dream Airlines ERJ-170

Obesity Week at FDA: Two Milestones

FDA (the U.S. Food and Drug Administration, not Fuji Dream Airlines) has set two big milestones for this week in obesity. They both fall on Thursday. Though the real Obesity Week is not until November 2, FDA is creating its own version this week.

The first is a bit of old business that is really past due. The combination drug variously known as Contrave, NB32, or buproprion/natrexone was first recommended for approval by an FDA advisory committee back in 2010. But FDA said, not so fast, and required a cardiovascular safety study before they would approve it. In the meantime two other drugs — Belviq and Qsymia — were approved. A deadline for FDA to act on the resubmission of Contrave came and went in June, with FDA delaying their action date until September 11. So people who care about having more options for treating obesity are sitting on the edge of their seats, waiting for the word.

The second milestone is the consideration of liraglutide — a drug already available for treating type 2 diabetes — for use at a higher dose to treat obesity. For diabetes the drug is known as Victoza. For obesity, it will be called Saxenda.

FDA has just released the full briefing documents for an expert advisory committee hearing that will take place on Thursday. Those documents make it clear that FDA and the company (Novo Nordisk) agree that the drug meets FDA criteria for efficacy. Clinically significant (≥5%) weight loss was achieved and maintained by 60% of patients while taking liraglutide 3mg.

So the real question that the expert panel will weigh on Thursday will be safety. Though the data on cardiovascular data seem solid, FDA reviewers seem to be leaving the door open for questions on the day of the panel. But the safety discussion appears more likely to center upon pancreatitis. Liraglutide is already labeled for close monitoring of this potential adverse effect. In 3,291 patients studied with the 3mg dose, 0.4% experienced pancreatitis. The company has proposed a program of post-marketing surveillance to monitor for risk of this and other adverse events.

A few years ago the bias was so great against approving any obesity treatment, that any adverse events served as an excuse to keep drugs off the market. Then came the approval of Belviq and Qsymia with a more balanced consideration of risk and benefit.

FDA actions this week will tell us if that balanced perspective continues to hold sway.

Click here to read more from Bloomberg and here to access the briefing documents for liraglutide.

Fuji Dream Airlines ERJ-170, photograph © Kentaro IEMOTO / flickr

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