Last year turned out to be a disappointing one for new drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015's tally of 45.
Across the Atlantic, the European Medicines Agency recommended 81 new prescription products against a 2015 total of 93. Unlike the FDA, the EMA includes generic drugs in its list.
The slowdown suggests the pharmaceuticals industry may be returning to more normal productivity levels after a spike in approvals in 2014 and 2015, when the haul of new drugs reaching the market hit a 19-year high.
Several factors led to the fall in the approval rate in 2016, John Jenkins, the FDA's director of the office of new drugs, told a conference last month.
Notably, five new drugs that had been scheduled for approval in 2016 ended up winning an early green light at the end of 2015. There was also a decline in drugs being filed for approval and the FDA rejected or delayed more applications in 2016 than in the previous two years.
Some of the delayed drugs may yet go on to win approval in 2017, including Roche's multiple sclerosis treatment Ocrevus and Sanofi and Regeneron's sarilumab for rheumatoid arthritis.
Most industry executives remain upbeat about the hunt for new medicines, given recent advances in fighting cancer and an improved understanding of the genetic basis of other diseases, which has resulted in full development pipelines at many firms.Read More...
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