Novel drug approvals in the US have soared to a 19-year high, as the industry continued to hone its R&D focus on treatments for orphan diseases and personalised medicine.
Last year, 45 new medicines were given a green light by the US Food and Drug Administration, overshooting the 2014 figure of 41, the record since 1996. Also, for the second consecutive year the regulator cleared a record number of rare diseases therapies, which accounted for more than 40% of new approvals.
Similarly, across the pond, 93 therapies were recommended for approval in 2015 by European regulators, 11 more than in the prior year.
Analysts believe the rise reflects pharma’s improving ability to prioritise the most promising candidates in its R&D pipelines, but significant challenges remain.
For one, according to Bernstein analyst Tim Anderson, the time to discover and develop a new drug has been on the rise for more than a decade, averaging at about 14 years compared to 11 years in the 1990s, reports the Associated Press.
Nevertheless, IMS Health is forecasting that this rising trend of approvals will continue, with 225 new drugs expected to receive clearance between 2016 and 2020, compared to 184 for the 2011-2015 period, of which cancer treatments will represent the largest category.
