exenatide implant (ITCA 650/12M) / i20 Therap - LARVOL DELTA

INTARCIA’S DIABETES DRUG-DEVICE IMPLANT UNANIMOUSLY REJECTED BY ADCOMM (Pharmalive) - "The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Thursday unanimously voted against Intarcia Therapeutics’ investigational drug-device combination product ITCA 650 (exenatide in DUROS device) for the treatment of type 2 diabetes. All 19 panelists found that the benefits of the implantable drug-device combination did not outweigh its risks from potential side effects. In particular, the panel flagged the high rate of acute kidney injury in patients assigned to the treatment group, which they contend could potentially be attributed to ITCA 650."

FDA event • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus