Semaglutide Clears Two Important Hurdles

This is a big week for semaglutide – a promising cousin of liraglutide. Research is ongoing to figure out just how good it will be in both type 2 diabetes and obesity. And the milestones this week were all about diabetes. But you can find some encouragement for the obesity indication, too.

Unanimous Support from FDA’s Expert Advisors

Yesterday, a panel of experts voted unanimously (16-0) in favor of FDA approving injectable semaglutide for type 2 diabetes. One panel member, Yves Rosenberg, abstained.

Nephrologist and panel member Paul Palevsky called the benefit in controlling diabetes “impressive.” He added that there was “no signal for cardiovascular harm” and concerns about retinopathy were “modest and outweighed by the benefit seen.”

This outcome was not a total surprise. Earlier in the week FDA released a relatively positive briefing package for the advisory committee. Typically, those briefing documents highlight all the problems with a drug. That sets up the committee for a thorough discussion of them. But in the case of semaglutide, the only big issue was the data on retinopathy.

This advisory committee vote clears the way for an FDA approval in December. If approved, it will be the second GLP-1 agonist available for once-weekly use in type 2 diabetes. The first was Trulicity (dulaglutide).

Evidence That Oral Semaglutide Works

The good news doesn’t stop with FDA. Another big piece of good news came with a new study published in JAMA. In randomized, placebo-controlled trial, oral semaglutide worked better than placebo for controlling type 2 diabetes. The study was only six months, so more research will certainly follow.

But this is big news. Every other drug in this class (GLP1 agonists) is an injection. The application under review at FDA is for a once-weekly injection. Even just once a week, needles are no fun. Having an oral form will be a big help. Even more intriguing is the fact that the higher oral doses seemed to work as well as the injectable form.

And finally, even though this wasn’t a weight loss study, the data did show some respectable weight reduction. At a wide range of doses, the average weight loss ranged from 5 to 15 pounds.

These are early data, but they are certainly encouraging.

For more on the advisory committee hearing, click here and here. For the study in JAMA, click here.

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October 19, 2017