Report: FDA New Drug Approvals Dip in 2016

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A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

FDA approval of new molecular entities (NMEs) took a sharp decline in 2016 according to a new report released in January 2017 from HBM Partners. In 2016 FDA approved 19 new therapeutic drugs compared to 45 in 2015, the report noted. The official number of novel drugs approved by FDA’s Center for Drug Evaluation and Research (CDER) in 2016 was 22, but this number includes two imaging agents and one antidote, which were not included in the HBM report number.

In a presentation, John K. Jenkins, MD, director of the Office of New Drugs for CDER said the low number of approvals in 2016 is related to a high number of complete response letters issued in 2016 (12 in 2016 compared with 2 in 2015) and five new drugs approved faster than anticipated, which boosted 2015 numbers. Despite the dip of approvals in 2016, however, HBM said it believes FDA drug approvals will continue to see a positive trend in upcoming years. But, seeing more than 40 NME approvals per year should not be considered a “new normal.”

A number of big pharma companies had zero NMEs approved in 2016. This list includes notable names such as Johnson & Johnson, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Takeda, and AstraZeneca. Biogen, Merck & Co., and Eli Lilly each earned two NME approvals in 2016. But the HBM report asserts big pharma isn’t necessarily to blame for the drop in drug approvals. Mid-sized and smaller pharma/biotech companies also saw decreases in approval numbers.


Only four cancer drugs were approved in 2016, more than any other therapeutic area, although cancer drug approvals were down from 15 in 2015. Approximately half of the drugs approved in 2016 were acquired through mergers and acquisitions, or in-licensed, the report said. The report also noted that drugs developed in house have a higher percentage of approvals.

Source: HBM Partners