Going through some pharmaceutical trade publications today and saw a few interesting things...
Of all the FDA Advisory Committees, the Anti-Viral Drug Product Committee had the fastest average review time (time from NDA submission to approval) of all committees -- an average of 6.1 months for the 3 agents it approved last year. Viracept(Agouron) was the fastest at 2.7 months, and Aldara(3M) happened in 7.0 months (interestingly, it is an immune response modifier -- for warts). Also noticed that the Center for Drug Evaluation & Research announced on March 20 that it is instituting a formal policy of "fast track" designations for drugs "if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition." These fast track designations would require the FDA to meet a 60-day response requirement in all cases. Apparently, they have already received requests from manufacturers (IMNR?) to obtain this designation and some agents have already received this designation. I've put in a call to the Executive Secretary of the Antiviral Drug Advisory Committee in an attempt to discern whether IMNR is among those who have made this request (doubtful at this stage but you never know; plus I'm not sure if this is a request that would need to be made in advance of disclosure of the interim Phase III results). Interestingly, too, is that REMUNE's qualification as an IND with expanded access (in 10/96) means by the FDA's definition for drugs which can qualify for this status that, "Treatment IND status allows the use of an investigational new drug to treat immediately life-threatening and serious disease conditions for which there is no comparable or satisfactory alternative therapy available." Not to stir up the May expidited approval pot too much, but that sure sounds a lot like the requirements for drugs which can qualify for "fast track" approval. Hopefully, REMUNE's efficacy is there and the FDA will treat it in a manner consistent with other HIV medications. By the way, the Medical Officers who headed the reviews for each of the antiviral agents approved last year were as follows: Stanka Kukich, MD (Aldara), Samuel Maldonado, MD (Viracept), and R. Douglas Pratt, MD (Rescriptor). Anybody know anything about these physicians or if they have any history with IMNR? Let's keep the information flowing... |
