First-time drug approvals in the US reached a 19-year high in 2015, with 45 new therapies receiving clearance by the FDA, up from 41 the previous year. The figure represents the highest total of new drug approvals since 1996, when 53 drugs were approved by the agency. Meanwhile, 93 therapies were recommended for clearance by the EMA in 2015, compared to 82 in the preceding year.
The most highly publicised approvals of 2015 included Valeant Pharmaceuticals' hypoactive sexual desire disorder therapy Addyi (flibanserin), which was cleared in August after previously being rejected by the agency on two occasions. Valeant gained Addyi through its acquisition of Sprout Pharmaceuticals that same month. Other notable approvals by the agency were Amgen's oncolytic immunotherapy Imlygic (talimogene laherparepvec) for the treatment of melanoma and Aprecia Pharmaceuticals' epilepsy treatment Spritam (levetiracetam) as the first 3D-printed drug cleared by the regulator.
Analysts noted that drugmakers have gotten better at selecting the most promising candidates for development. According to data analysed by Bernstein analyst Tim Anderson, one in 13 early-stage drugs reach the market currently, compared to one in 19 between 2007 and 2011. "These improvements hopefully reflect the pay-off from the industry's conscious decade-long efforts to 'turn around' R&D," Bernstein previously stated.
While analysts expect the rapid pace of drug approvals to continue, IMS Health anticipates 225 new drug approvals worldwide between 2016 and 2020.
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