Boost seen to new drug approvals

European Medicines Agency building in Canary Wharf, London

Figures showing an increase in the number of new drug approvals in the United States and Europe so far in 2017 have countered concerns that medicines research and development was slowing down.

So far this year 21 new prescription medicines have been licensed for sale by the US Food and Drug Administration compared with just nine at the same stage in 2016 and 22 in the whole 12 months.

The European Medicines Agency, whose figures also include generic or non-patented drugs, has recommended 42 medicines so far in 2017 compared with 31 in the first five months of last year and 81 overall, figures collated by QuintilesIMS show.

2016 saw the lowest number of new medicines approvals for six years which had prompted concerns of reduced investment or productivity in drug development or that the regulation process was slowing down.

One potential reason for the unusually low figures for 2016 is some early approvals seen at the end of 2015, while other treatments had been delayed in the regulatory process until 2017.

QuintilesIMS concluded that the robust state of the industry’s late-phase R&D pipeline means it is well placed to yield an average of 40–45 new launches annually through to 2021.

One analyst at KPMG told Reuters that regulators, particularly in the United States, were showing innovative approaches that were helping to speed up approvals. But because many newer drugs were targeted to very specific patient groups there was a limit to the number of people who would benefit from novel medicines.

Last updated
The Pharmaceutical Journal, PJ, June, Vol 298, No 7902;298(7902):DOI:10.1211/PJ.2017.20202872

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