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Drug Approvals Declined In 2010

Regulation: Industry faced tough FDA scrutiny of new products

by Ann M. Thayer
January 10, 2011 | A version of this story appeared in Volume 89, Issue 2

FDA approvals of new small-molecule and biologic drugs decreased last year after a two-year plateau. In 2010, the first full year under a new commissioner, U.S. regulators approved 21 new drug substances, down from 25 in 2009 and 24 in 2008.

Full FDA performance statistics are not yet available for 2010, but the total number of new applications filed has been rising since 2005, mostly for new indications and formulations. Applications for new molecular entities have remained nearly constant.

Most of the notable 2010 approvals came in the second half of the year. They include Amgen’s osteoporosis drug Prolia, Novartis’ multiple sclerosis therapy Gilenya, and Boehringer Ingelheim’s anticoagulant Pradaxa.

As telling as those drugs that made it through, however, are drugs that failed to get approved, were recalled, or have been delayed. In 2010, the agency rejected a long-acting form of the diabetes drug Byetta from Amylin Pharmaceuticals and Eli Lilly & Co., as well as weight-loss drugs from Arena Pharmaceuticals and Vivus.

Regulators also took a firm stand on safety. Heart problems were behind the withdrawal of Abbott Laboratories’ weight-loss drug Meridia and the generic painkiller propoxyphene. On the same grounds, FDA limited the use of GlaxoSmithKline’s diabetes drug Avandia.

And in a recent high-profile case, FDA has proposed removing breast cancer from the indicated uses for Roche’s blockbuster drug Avastin. The agency’s safety-based decision ran counter to the European Medicines Agency’s view.

Some FDA decisions were shifted into 2011. The agency will take more time to review MannKind’s inhaled insulin Afrezza, AstraZeneca’s blood thinner Brilinta, Bristol-Myers Squibb’s ipilimumab cancer therapy, and Benlysta, a lupus drug from Human Genome Sciences and GSK.

Michael Kleinrock, director of market insights at the research firm IMS Health, notes that the lower number of approvals in recent years has been accompanied by lower average sales from those approvals. If this trend were to continue, there could be long-lasting negative implications, he says, “but the industry has experienced this in the past and has rebounded.”



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