U.S. new drug approvals slip in 2013 vs prior year

Mon Dec 30, 2013 10:04pm GMT

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Dec 30 (Reuters) - The number of new drugs approved in the United States fell in 2013 compared with the previous year as fewer applications were filed, though several products for hard-to-treat diseases were approved in record time.

The U.S. Food and Drug Administration approved 27 new drugs in 2013, down from a banner year in 2012 which saw 39 drugs approved, the greatest number since 1997 according to FDA data.

The regulatory agency attributed the drop in approvals in 2013 to fewer applications. As of Dec. 11, 32 applications had been filed, compared with 41 for 2012, the FDA said. Over the past five years, the average number of new drug filings per year was 35.

In July 2012, as part of the Food and Drug Administration Safety and Innovation Act, the FDA introduced the "breakthrough therapy" designation to help speed drugs to market that treat serious or life-threatening conditions and where preliminary evidence suggests the drug may work better than existing treatments.

The FDA's Center for Drug Evaluation and Research (CDER) has received 120 requests for breakthrough therapy designation, of which it has granted 36 requests and denied 58. The remainder were pending or withdrawn at the end of the year.

The agency has approved three products so far under the breakthrough therapy program: Roche Holding AG's leukemia drug Gazyva; Johnson & Johnson's drug Imbruvica for mantle cell lymphoma, a rare form of non-Hodgkin lymphoma; and Gilead Sciences Inc's hepatitis C drug Sovaldi.

The number of drugs approved by CDER in 2013, though down from 2012, is close to the historical average over the past five years of 28, according to a recent FDA industry presentation.

The average internal rate of return from pharmaceutical research and development fell to around 4.8 percent in 2013 from 7.2 percent last year and 10.5 percent in 2010, according to a study released earlier this month by Deloitte and Thomson Reuters.

Over the same four-year period, the average cost of developing new medicines rose 18 percent to $1.3 billion, the report found. Yet the average peak sales forecast for each new drug dropped 43 percent to $466 million in 2013 from $816 million in 2010, the report found.

Nonetheless, some analysts remain optimistic that output will increase along with advances in science.

"We are confident that changes to R&D strategies ... will drive a significant improvement in output over the next decade," a Deutsche Bank report said this month.

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