Drug Approvals Up for 2011

The FDA approved 30 drugs last year, the highest number in the last 7 years.

By | January 9, 2012

A cocktail of antibiotics and other drugsIMAGE: FLICKR USER EMILYBEAN

The US Food and Drug Administration approved 30 drugs in 2011, compared with 21 in 2010, according to an analysis by Bloomberg News. That number is the highest since 36 drugs were approved in 2004.

Some of the headline drugs to get the green light include Yervoy, a drug that primes the immune system to attack melanoma; Xarelto, which reduces clotting for patients with irregular heartbeats; and Benlysta, the first lupus drug approved in 50 years.

The FDA toughened its data requirements in 2007, after critics faulted its response to claims of heart problems associated with pain drug Vioxx and diabetes drug Avandia, resulting in an overall drop in new drug approval rates. But more recently, the agency has begun holding advanced meetings with companies, which may help smooth the path to approval. Some analysts also credit pharmaceutical companies for anticipating FDA's requirements and focusing on more productive avenues of research. “I think people have realized that FDA has gotten more difficult and they’re improving what they turn in,” Yaron Werber, an analyst with Citigroup Inc., told Bloomberg News.

(See The Scientist’s list of other headline-worthy drugs from last year.)


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