Want more proof that achieving FDA approval is more difficult than in the past? A study released by the BIO and BioMedTracker that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previously the rate of approval were one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development. And large molecule drugs are twice as likely to be approved than than small molecule drugs.
"This groundbreaking study highlights the depth and breadth of risk inherent in the drug development process more comprehensively than any other previous study," said Alan Eisenberg, Executive Vice President of Emerging Companies and Business Development at BIO. "Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing." The study results will be fully explored at a BIO CEO & Investor Conference panel on Tuesday.
- here's the release