Intarcia's ITCA 650 heading for 3Q submission

Intarcia Therapeutics Inc. (Boston, Mass.) said ITCA 650 met the primary endpoint in the Phase III FREEDOM-CVO cardiovascular outcomes study to treat Type II diabetes. The company said it plans to submit a regulatory application next quarter to FDA for ITCA 650, which provides continuous subcutaneous delivery of glucagon-like peptide-1 (GLP-1) receptor ( GLP-1R; GLP1R) agonist exenatide via the implantable Duros osmotic mini-pump.

In a meta-analysis of patients in FREEDOM-CVO and its three other Phase III studies, Intarcia said ITCA 650 met the study's primary endpoint, which was to show that the treatment did not lead to an increase in risk of at least 80% for major cardiovascular events (MACE). The endpoint was designed to meet FDA's pre-approval safety requirement for diabetes products. The agency also requires companies to rule out a 30% increase in risk post-approval. ...