The FDA’s Center for Drug Evaluation and Research approved 21 new molecular entities (NMEs) in 2008, up from 16 the year before. Three biologic license applications (BLAs) were approved, compared to two in 2007. Three of the NMEs and one of the BLAs were delayed approvals. The drugs with the fastest approval times tend to be those for rare disorders or severe diseases, according to Eric Schmidt of Cowen & Company. In addition to faster approval rates, these areas of drug development are also popular, according to McKinsey & Company’s Philip Ma, because they are targeted therapies, fill an unmet need and face less pricing pressure from payers. The number of new drugs given priority review last year was nine, the same as 2007. Regulatory delays were also a trend. Between January and October 2008, the FDA failed to meet its goal of standard reviews within 10 months and priority reviews within 6 months for 32 of the 159 applications. Reasons given for the delay included an increased workload and a new requirement that each new chemical entity be referred to an advisory committee. Some observers believe that the new requirement for Risk Evaluation and Mitigation Strategies may have also delayed approvals.

Source: Nature Reviews Drug Discovery

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