2011 – Highest Level of FDA New Drug Approval since 2004

The just published annual FDA review from Nature Reviews Drug Discovery finds a rebound in new drug approvals. With 24 new molecular entities and six new biologics receiving first-time marketing clearance, 2011 was the most active year since 2004 when 31 NMEs and five biologics were approved. The trend towards narrowly-focused therapeutic categories continued with 11 of the new drugs being designated as orphan drugs. Cancer was the single largest area of activity, representing 35% of approvals, the majority of these were also orphan drugs. Nonetheless, the fading blockbuster categories also showed some life as hypertension, major depressive disorder, and Type 2 diabetes each saw a single new approval.In part, the 2011 upswing is attributed to a higher success rate for applications. The FDA has approved half of applications in recent years but last year the rate improved to over 80%. It seems likely that there will be some reversion to the mean in 2012 but one can hope that improvements in trial design, submissions, and perhaps also in regulatory attitudes might sustain the trend to some degree going forward.


Todd Clark
Todd Clark

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