US FDA panel votes against diabetes implant due to safety concerns

By Mariam Sunny

(Reuters) – A panel of external advisors to the U.S. Food and Drug Administration voted against Intarcia Therapeutics’ diabetes treatment implant on Thursday, citing risks from potential side-effects.

The committee unanimously held that the benefits of the drug-device combination for the treatment of type 2 diabetes did not outweigh its risks, pointing to the need for additional safety data.

The decision comes on the back of two previous rejections by the health regulator owing to the drug’s potential acute kidney injury (AKI) and cardiovascular risks. While the FDA usually follows the recommendations of its expert panel, it is not obligated to do so.

In briefing documents published on Monday, the agency’s staff reviewers separately identified an “imbalance” in the number of AKI issues reported in the treatment group, versus the placebo group.

The matchstick-sized drug-device candidate, called ITCA 650, uses a pump that can be implanted under the skin to deliver the drug exenatide – also the active ingredient in AstraZeneca’s Bydureon – on a sustained basis for up to a year, to treat type 2 diabetes.

When operating optimally, the device could be a game changer, said Robert Greevy, one of the FDA panelists. However, he said the data presented was insufficient for them to be convinced this was the best version of the device.

Exenatide belongs to a class of drugs known as GLP-1 receptor agonists, which help control blood sugar in patients with type 2 diabetes and also work to suppress the appetite and promote a feeling of fullness.

Originally developed to tackle diabetes, GLP-1s have gained traction as weight-loss treatments and are in overwhelming demand in the United States.

Intarcia, once touted as a biotech unicorn, is now a subsidiary of privately owned i2o Therapeutics.

(Reporting by Mariam Sunny in Bengaluru; Editing by Pooja Desai)


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