The approval rate for new drugs has been cut in half from previous years, according to a February study conducted by the Biotechnology Industry Organization and BioMedTracker. More than 4,000 drugs were part of the study, which involved data from 2004 to 2010 and found a success rate of one in 10 from Phase I to FDA approval. About 63% of drugs in Phase I advanced to Phase II, but only 33% of drugs in Phase II made it to Phase III. Applications to approve pharmaceuticals were filed for 55% of the drugs in Phase III, and 80% of those ultimately were approved, a decline from 93% in earlier years. The chances of biologics and small-molecule chemical drugs progressing from Phase I to FDA approval were 15% and 7%, respectively. The most successful therapeutic category was infectious diseases with 12%. The lowest was cancer drugs with 4.7%.

Source: Reuters