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FDA approves fewest drugs since 1983

The FDA approved 19 new drugs in 2007, the fewest in 24 years, after pharmaceutical companies focus on developing uses for existing products

According to a Bloomberg report, the FDA approved 19 new drugs in 2007, the fewest in 24 years, after pharmaceutical companies focused on developing uses for existing products.

Total approved new treatments medicines, including novel drugs and biologics, was three less than in 2006, according to analysts. The FDA did not confirm the numbers. Approvals included GSK's Tykerb (lapatinib) for breast cancer and Novartis' Tasigna (nilotinib) for leukaemia.

The FDA lists 14 new molecular entities (NMEs) approved by November 2007. Three more were approved in December, bringing the total to 17, according to Washington Analysis. The agency also approved two new biologic treatments.

In an interview with Bloomberg, Kenneth I Kaitin, director of the Tufts University Center for the Study of Drug Development in Boston, said that pharma companies have shifted emphasis to altering drugs and seeking more diseases to treat with them, at the expense of developing new products.

ìThey got away from their core mission, which was to bring new medicines and new treatments to market. If you're putting money into extending the lifecycle of a drug on the market, you're taking money away from a drug development programme,' continued Kaitin.

The companies are getting back to developing new treatments, and the annual approval numbers should increase in coming years, Kaitin concluded.

Novartis and GlaxoSmithKline (GSK) each had two new drugs approved in 2007, the most of any companies.

The FDA is under pressure from the US government to raise the bar regarding drug safety since a number of high profile cases, including Merck & Co's Vioxx (rofecoxib) and GSK's Avandia (roseglitazone), both of which were connected with an increased risk of cardiovascular damage. 

In an e-mail exchange with Bloomberg, Janet Woodcock, the FDA's deputy commissioner, said that the number of marketing applications for novel drugs had declined in recent years, and the agency was better able to detect risks.

ìOur standards for what constitutes a safe, effective drug have not changed. But our ability to analyse data for potential safety problems has improved, and we're especially vigilant when we're evaluating drugs for chronic conditions: drugs that people will be taking daily for many years,' added Woodcock. 

Raymond Woosley, president of the Critical Path Institute in the US, said that companies were increasingly developing drugs to treat the cause of diseases rather than common symptoms, which were easier to target.

"If you go after the basic cause of the disease, it's just much more complex' and many such drugs fail during human testing. A lot of these don't get to the FDA," concluded Woosley.

8th January 2008

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