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Experts Agree Jardiance Reduces Cardiac Deaths

Late yesterday, expert advisors to the FDA voted by a margin of 12-11 that the diabetes drug Jardiance (emagliflozin) does indeed cut the risk of cardiovascular deaths for patients with type 2 diabetes who have a history of cardiovascular disease. The committee was unanimous in its agreement that the drug offers good cardiovascular safety. But the vote was much closer on the question of whether it clearly protects against cardiovascular deaths.

A vigorous debate in the committee centered on the question of whether the results of the EMPA-REG study offered sufficient evidence to support the new claim for Jardiance. Brown University Professor Robert Smith, chair of the FDA Endocrine and Metabolic Drug Advisory Committee, characterized the data as “very robust” but also noted the need to replicate the finding in another study.

FDA is not bound to follow the committee’s recommendation, but more often than not it does. If FDA grants approval for this claim, it will make Jardiance the first treatment for type 2 diabetes proven to reduce the risk of cardiovascular death.

Jardiance is a relatively new drug in a class known as SGLT2 inhibitors. Unlike many older drugs for diabetes, SGLT2 inhibitors tend to cause a little bit of weight loss. However, obesity treatment is not an indication for SGLT2 inhibitors.

Today’s decision marks another milestone in a trend that favors weight-sparing drugs for the treatment of type 2 diabetes. Increasingly, physicians are avoiding older drugs for type 2 diabetes that may cause weight gain.

Another notable example of a weight-sparing diabetes drug is liraglutide. It is marketed for diabetes as Victoza and at a higher dose for obesity treatment as Saxenda. Novo Nordisk, the maker of Victoza, has said that it, too, will seek an indication for Victoza to reduce the risk of cardiovascular deaths.

Click here for more from Reuters and here for more from FiercePharma. If you want to dive into the details, click here for the FDA briefing paper for yesterday’s hearing and here for the briefing paper from the manufacturer.

Lock My Heart Here, photograph © Davide D’Amico / flickr

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June 29, 2016