Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus.
The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee Act target action date is set for March 9, 2020, according to a news release.
Using Intarcia’s Medici drug delivery system, ITCA 650, is designed to enable subcutaneous delivery of exenatide using a matchstick-sized osmotic pump placed under the skin in a patient’s abdominal area during an in-office procedure.
The FDA rejected ITCA 650 in September 2017, with Intarcia suggesting that the reason was related to the manufacturing of its implant, saying that it had received “clear and constructive guidance from the agency” regarding the drug-device combination product’s manufacturing.
In February 2018, privately-held Intarcia cut 60 employees and received a clinical hold for two of its ongoing marketing studies, following the FDA rejection months earlier. Approval would make ITCA 650 a new, twice-yearly delivery system of a glucagon-like peptide-1 (GLP-1) receptor agonist for maintenance therapy of Type 2 diabetes.
