Intarcia Therapeutics, Inc. looks unlikely to shift the US Food and Drug Administration’s mind on the non-approvability of its drug-device implant for type 2 diabetes following a unanimous 19-0 advisory committee vote that the sponsor failed to demonstrate that the benefits of the combination product outweigh its risks.
But the Endocrinologic and Metabolic Drugs Advisory Committee acknowledged at the 21 September meeting that they could see a potential use case for ITCA 650, which delivers a formulation of...