Monday, December 31, 2007

The Anatomy Of An Approved Drug

Ever wondered what a drug that gets approved by the FDA looks like? What are the most common types of drugs that the agency approves, and what other characteristics improve a drug's chances for approval? If you've pondered these questions, then you're in luck: In 2006, the FDA released a review examining the drugs that get approved by the agency and their characteristics.

Overall, 47% of the 77 drugs reviewed from 2002 through 2004 were approved the first time they went up for approval; 23% were approved after resolving approvable-letter concerns; 5% were issued not-approvable letters; and the remainder had approvable-letter concerns that had not been resolved by the time the report was issued. Cumulatively, then, at least 70% of drugs making it to the FDA review process went on to get approved.

The Milken Institute (opens PDF) pegged the approval rate for new molecular entities under review at 81% in an earlier 2002 report. The FDA report cited 73% of drugs treating a life-threatening condition with a new mechanism of action as getting approved on the first go-round from 2002 through 2004. A drug like Genentech's (NYSE: DNA) Avastin falls into this category.

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