The FDA cleared 22 novel therapies last year, down from 45 in 2015, making it the lowest number of approvals since 2010. John Jenkins, director of the FDA's office of new drugs, cited several factors for the decrease, including early approvals in 2015 of five drugs that were originally expected to receive clearance last year. In addition, there were fewer marketing applications filed in 2016, while the FDA rejected or delayed more submissions than it had in the prior two years.
Some drugs that did not receive approval in 2016, including Roche's multiple sclerosis drug Ocrevus (ocrelizumab), as well as Sanofi and Regeneron Pharmaceuticals' rheumatoid arthritis therapy sarilumab, could potentially be cleared this year. The FDA recently extended its review of Ocrevus until March 28 after Roche submitted additional data about the commercial manufacturing process, while the regulator declined to approve sarilumab in October after identifying "certain deficiencies" at a Sanofi manufacturing facility in France.
Meanwhile, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended 81 new branded and generic prescription products for approval in 2016, down from 93 in the preceding year.
The decline in US approvals comes amid increasing scrutiny over drug pricing in the country. Biogen and Ionis Pharmaceuticals announced last week that their recently approved spinal muscular atrophy therapy Spinraza (nusinersen) will cost $750 000 per patient in the first year and $375 000 in subsequent years, a pricing decision Leerink analysts said could result in "a storm of criticism."
Last month, US President-elect Donald Trump promised to take steps to address rising drug costs in the country. For additional analysis, see ViewPoints: Allergan CEO says Trump victory no panacea for drug pricing debate. See also Spotlight On: Diversification, M&A and continued US pricing pressure likely to shape pharma in 2017, argue industry executives.
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