Toxicology Research at FDA

Semaglutide in for Review at FDA to Treat Obesity

Friday marked an important milestone in progress toward better treatments for obesity. Novo Nordisk submitted semaglutide to FDA for approval in treating obesity. So we may see approval for this important new drug in the second half of next year.

Why so important? We have two reasons.

A Step Forward in Effectiveness

The first reason is that clinical trial results suggest that this drug may offer better efficacy than current options can offer. Most anti-obesity medicines can help people lose fat mass and maintain a body weight that is five to ten percent lower than where they started. This represents an average. So some people lose no weight at all. But a very few might lose as much weight as is typical with bariatric surgery – 20 percent or more.

The average of five to ten percent with current drugs is enough to produce important health benefits. Blood pressure goes down, so does cholesterol. Markers of diabetes improve. You might call these benefits somewhat subtle, but important for health.

However, with semaglutide, research data suggest that efficacy will be about twice as good. In a pivotal study presented at ObesityWeek, subjects lost an average of 16 percent of their baseline weight after 68 weeks of treatment.

This level of effectiveness does not quite match the effectiveness of gastric bypass surgery. But it is a step toward that goal.

An Effect on Major Cardiovascular Outcomes?

The second reason this drug is important is more speculative. It holds the potential to answer a pivotal question. Can can anti-obesity medicines reduce the risk of heart attacks, strokes, and death?

We know that the effectiveness of bariatric surgery is sufficient to do this. From the Look AHEAD study, we also know that very intensive behavioral programs are not sufficient. Likewise, older anti-obesity meds, with their more modest efficacy, have not yielded such a benefit.

However, a study of more than 17,000 patients with semaglutide will tell us if this drug’s efficacy can yield a benefit in survival and cardiovascular outcomes. The SELECT study started in 2018 and is due to be complete by 2023. Whatever the results tell us it will be a big deal. Already we know that semaglutide produces a survival benefit when given in lower doses for diabetes. So we are hopeful about the prospects in obesity care.

Indeed, the submission of semaglutide to FDA for approval to treat obesity is a big milestone. It could lead to a big step forward in obesity care.

Click here for more on this submission, here for more on recent study results, and here for more on the SELECT study.

Toxicology Research at FDA, FDA photograph by Michael J. Ermarth / Wikimedia Commons

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December 7, 2020