FDA hits the highest level of drug approvals in 18 years

The FDA cleared 41 new medications in 2014, the highest level for the agency since 1996, when a record 53 new products were approved. The total was also 14 more than the number of drugs the agency approved in 2013.

Of those new medicines approved last year, nearly 40 percent were treatments for orphan diseases, the most ever cleared by the US regulator in a single year. Among these drugs were Amgen's Blincyto (blinatumomab), which was granted accelerated approval by the FDA for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia in December, and Aegerion Pharmaceuticals' lipodystrophy therapy Myalept (metreleptin), which the regulator approved in February. In addition, the FDA also granted its first approvals to drugs from the PD-1 inhibitor class last year such as Merck & Co.'s Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab). For related analysis, see ViewPoints: New cancer filings and approvals already overshadowed by PD-1 competitors?

Some industry experts suggested that the move toward specialty drugs is reflective of a natural research tendency. "Some of the larger population diseases that we've found treatments for have been solved, in essence," remarked Michael Kleinrock, director of research for IMS Health, adding "innovation is now moving to smaller populations, and they're more difficult both technically and in terms of the cost."

Health payers have expressed concerns over the growing prices of new therapies. Amgen recently disclosed that Blincyto would be priced at $178 000 for a course of treatment, while Myalept, which Aegerion purchased from AstraZeneca in November, was priced at about $325 000 a year.

Health benefit managers have been particularly critical of the price of Gilead Sciences' hepatitis C treatment Harvoni (ledipasvir/sofosbuvir), which the drugmaker launched at a price of $94 500 for a standard 12-week course of treatment following its clearance in the US in October. Pharmacy benefit manager Express Scripts, which said in December that Harvoni would not be included on its 2015 formulary, commented that the therapy "is priced as if it were treating an extremely rare condition." For related analysis, see ViewPoints: This means war! Impact of AbbVie's HCV deal with Express Scripts goes well beyond Gilead and Spotlight On: Harvoni's exclusion by Express Scripts may be good news for biosimilars manufacturers.

Meanwhile, the European Medicines Agency recommended 82 medicines for marketing authorisation last year, up from 79 in 2013 and 57 in 2012.

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