By COLLEEN CREAMER
For VerusMed
An average of 49 new drug candidates per year were granted fast track designation by the Food and Drug Administration from 2003 to 2007 compared with an average of 22 per year during the time period from 1998 to 2002, according to the September/October Impact Report from the Tufts Center for the Study of Drug Development (CSDD).
According to the study authors, the fast track program has evolved since it was authorized in 1997. To study the latest trends, the authors analyzed a Tufts CSDD database of 344 investigational drug candidates that received at least one FDA fast track designation between January 1998 and June 2008.
Results showed that few candidates in early development received fast track designation during the study period. Thus, some of the candidates that entered clinical development in the 2005-07 period might yet receive the designation.
Small molecule products received the most fast track designations (70 percent), but biologics, vaccines and a diagnostic also gained fast track status.
Cancer drugs received the most fast track designations since the program began, followed by anti-infectives, cardiovascular/hemostasis drugs, neuropharmacologics and immunological drugs.
A fast track designation is not an indicator that the drug will be approved, the authors noted. In fact, candidates that received the designation were terminated more frequently than non-fast track candidates were, with efficacy being the prime reason for termination of fast track candidates. Termination of fast track candidates due to efficacy accounted for 73 percent of the terminations in the 1998-2002 period and 49 percent of the terminations in 2003-07 period.
Overall, fast track candidates had shorter approval times than did drugs in total, with longer clinical development times offset by a shorter FDA approval time. Specifically, the FDA approval time was an average of 8.4 months for fast track candidates versus 15.8 months for drugs as a whole, but the average clinical development time was 64.7 months for fast track candidates versus 61.2 months for all drugs. The total clinical and approval time was 73.1 months for fast track candidates compared with 77 months for all drugs.
For cancer drugs, the total clinical and approval times were similar for fast track candidates and all cancer drugs (81 months vs. 81.4 months, respectively).
The trends seen in this study may change, the authors warned, noting that most of the 2003-07 fast track candidates are still in clinical studies.
–From VerusMed.com
