Significant decline in 1st-qtr US FDA drug approvals

Warning signs of a decline in pharma R&D activity and successes has come in the form of a new analysis of US regulatory approvals by a leading rating agency.

The number of US pharmaceutical approvals continued to decline in the first quarter of 2014 with the outlook for R&D mixed for the remainder of the year, according to a Fitch Ratings report.

The Food and Drug Administration approved six new molecular entities (NMEs) during the first quarter of 2014 compared with nine approvals in the prior year period. This is the lowest number of approvals in a quarter since before 2000. The FDA cleared 27 novel medicines for US marketing during 2013 in comparison to 37 in 2012. The five-year average at the end of 2013, however, was around 28.6 approvals.