FDA underscores quality, safety concerns with Intarcia’s diabetes treatment ahead of adcomm

Af­ter be­ing re­ject­ed twice by the FDA in the past six years, Intar­cia Ther­a­peu­tics’ drug-de­vice prod­uct to treat type 2 di­a­betes will be the sub­ject of an ad­vi­so­ry com­mit­tee meet­ing to­mor­row.

The FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee will con­vene to dis­cuss and vote on whether the ben­e­fits of Intar­cia’s IT­CA 650 out­weigh the risks. Intar­cia sought FDA ap­proval in 2017 and 2019, but was de­nied both times over qual­i­ty con­cerns and clin­i­cal de­fi­cien­cies.

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