An advisory panel to the Food and Drug Administration unanimously voted against a diabetes implant from Intarcia Therapeutics — a former biotech unicorn that faltered after the FDA rejected said implant not once, but twice.
Intarcia called for the panel meeting because of those two rejections, seeking outside input on the FDA’s decision. FDA then granted Intarcia’s request. The agency is not bound to advisory panel decisions, though it tends to follow their advice.
Intarcia started developing its lead therapy, a small, skinny bar implanted under the skin, for type 2 diabetes patients in 2016. The implant delivers a glucose-controlling medicine called exenatide, a member of the GLP-1 drugs that have taken the diabetes and obesity markets by storm. Intarcia’s implant continuously administers the drug over six months, with the goal of improving patient adherence compared to Eli Lilly and Novo Nordisk’s weekly GLP-1 shots.