Posted by Michael Wonder on 28 Sep 2017
Intarcia provides corporate update
27 September 2017 - Intarcia receives complete response letter from the FDA for ITCA 650.
Intarcia Therapeutics today announced that the U.S. FDA has issued a complete response letter for ITCA 650 (exenatide implant) for the treatment of type 2 diabetes. The company looks forward to meeting with the FDA and working closely together on next steps. Intarcia does not anticipate the need to conduct new pivotal trials or any long lead-time CMC activities in order to satisfy the requirements of the FDA.
The Company received clear and constructive guidance from the Agency regarding manufacturing aspects of the complete response letter and is on a clear path to move forward.
