Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes.
The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter.
Intarcia hinted that the reason behind the CRL is related to the manufacturing of its implant, saying that it has received “clear and constructive guidance from the agency” regarding the drug-device combination product’s manufacturing.
“Real-world outcomes data consistently demonstrate that the majority of patients living with Type II diabetes struggle to adhere to chronic pills and injections. Diabetes remains a devastating public health crisis that is still spiraling out of control because of poor control and poor adherence issues,” chairman, president & CEO Kurt Graves said in prepared remarks.
“We remain confident in the approvability of ITCA 650, and have an unwavering commitment to bring forward a new category of medicines that are fundamentally designed to address major unmet needs in diabetes and other serious chronic diseases.”