Editors note: This article has been corrected from an earlier version that included an imaging agent as a new chemical entity.

Drug industry optimists found little cheer in 2010, a year in which the U.S. Food and Drug Administration ratcheted up its expectations for new drugs, making approvals harder to achieve.

The FDA approved 24 new drugs during 2010, compared to 26 in 2009 and just 24 in 2008.

Chief among the most closely watched success stories were Novartis’ new multiple sclerosis pill, Gilenya, and Dendreon’s treatment for advanced prostate cancer, Provenge. A trio of obesity drugs were also closely watched. Two of those medicines—Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa—failed to gain approval, while a third, Orexigen Therapeutics’ Contrave still awaits FDA action.

Thematically, closer scrutiny of trial data, demands for new trial data, and higher expectations for efficacy defined the year.

A more judicious approach to safety issues seemed to develop at the agency, as it revisited several of its earlier decisions. It took steps to revoke its approval of Roche’s Avastin to treat metastatic breast cancer, pulled Abbott Laboratories’ weight-loss drug Meridia from the market, and moved to sharply restrict the use of GlaxoSmithKline’s Avandia.

In several cases, such as with AstraZeneca’s blood-thinner Brilinta, the agency’s more cautious approach led to requests for new trial data. In other cases, such as MannKind’s application for an inhaled-insulin product and the lupus drug Benlysta—developed by Human Genome Sciences and GlaxoSmithKline—there have simply been longer waits as the FDA sought more information before making a decision.

Both the FDA and industry are already gearing up in hopes of a better 2011. Initiatives in Washington are focusing on improved transparency and speed during the review process. Many of the world’s biggest drugmakers, meanwhile, are turning their attention outside the United States where they hope to find both promising new products to fill their pipeline, new market opportunities, and a friendlier regulatory environment.




NEW FDA APPROVED DRUGS AND BIOLOGICS IN 2010