Another action from the FDA today that gives a thumbs down to an investigational drug. Today Eisai announced that it had received a non-approvable letter for the investigational compound fospropofol disodium injection which has been in review at the FDA for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures.
The interesting part of this rejection is that it goes against advisory committee recommendation, which is supposed to be rare, but seems to be occurring with increased frequency in today’s environment.
Eisai was not as forthcoming as Vanda Pharmaceuticals was earlier today regarding their receipt of a non-approval letter and did not state the reasons for the FDA’s non-approval of the drug. The only thing the company did say in the subtitle of the press release was that the FDA’s letter did outline a path to approval. Eisai decided not to share what that path might be.