Intarcia's speed bump at the FDA turns into a roadblock, as regulators once again turn thumbs down on diabetes drug/device
Back in the fall of 2017, Intarcia CEO Kurt Graves handled the FDA’s rejection of its hotly promoted drug/device as something of a speed bump.
The problem was in the manufacturing of ITCA 650, the company noted, and they had a straight shot at getting it fixed and back up in front of the FDA as they barreled on to certain blockbuster status.
Things, though, didn’t quite pan out that way.
The privately-held biotech put out the word today — well over 2 years since the last CRL — that the FDA has once again rejected its therapeutic approach to diabetes, which centers on an implant that would provide a steady supply of reformulated exenatide to diabetes patients with twice-yearly tune-ups — fixing a compliance issue that dogs a huge number of patients.
The company’s new communications director, Sunny Uberoi, sent me Intarcia’s statement.
We are extremely disappointed with the receipt of a Complete Response Letter (CRL) from the FDA. We remain steadfast in our belief that ITCA 650 holds important potential as a new treatment option for people managing type 2 diabetes. We anticipate meeting with the Division for our end of review meeting to make sure we understand the situation and the path forward.
At one point Intarcia was one of the hottest tickets in biotech. But the IPO didn’t fly, and the one-time unicorn has had little to say about ITCA 650 in the long gap between FDA actions.