A study released Monday suggests that the success rate in bringing new drugs to market in the US is about one in 10, down from a rate of between one in five and one in six in previous years.
The report, which was conducted by the Biotechnology Industry Organization (BIO) Industry Analysis and BioMedTracker, reviewed more than 4000 drugs that moved from Phase I clinical trials to FDA approval from late 2003 to 2010. Overall success rates from Phase I to FDA approval for lead and secondary indications was nearly 9 percent. When separated, lead indications had close to a one in seven rate of approval whereas secondary indications had a rate of one in 30. The analysis also found that traditional drugs had an approximately 7-percent chance of receiving approval from US regulators, while biologics had a 15-percent success rate.
Looking at therapeutic categories, the trade group reported that drugs for infectious diseases had the highest rate of approval at 12 percent, followed by endocrine system therapies at 10.4 percent and autoimmune disease treatments at 9.4 percent.
At the other end of the spectrum, oncology therapeutics had the lowest rate of success at 4.7 percent, a finding that BIO managing director John Craighead said was likely due to the fact that the design of these studies varies so significantly and because making extending survival a primary endpoint can be difficult to achieve. Cardiovascular drugs had the second lowest rate of approval at 5.7 percent.
**Published in "First Word"
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