Intarcia gets CRL for Type II diabetes candidate ITCA 650

FDA issued a complete response letter to an NDA for ITCA 650 from Intarcia Therapeutics Inc. (Boston, Mass.) to treat Type II diabetes. The company said it plans to resubmit the NDA after meeting with FDA this year.

ITCA 650 provides continuous subcutaneous delivery of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, via the implantable Medici Drug Delivery System. Servier (Neuilly-sur-Seine, France) has exclusive rights from Intarcia to develop and commercialize ITCA 650 outside the U.S. and Japan (see BioCentury, Nov. 17, 2014)...