Why 2016 drug approvals fell

January 2, 2017

While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.

While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.

As of December 9, 2016, FDA approved 19 new therapies, compared to a significant 45 new drugs in 2015.

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However, the latest data from FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (CDER) also does not include existing drugs that were approved for new indications. For example, bevacizumab (Avastin, Genentech), which treats a variety of cancer types, was recently received the expanded indication for certain types of ovarian cancer.

In addition, five new drugs that had been scheduled for approval in 2016 received early FDA approval at the end of 2015, John Jenkins, director of the Office of New Drugs, said at a recent conference, according to Reuters.

Jenkins also that pharmaceutical manufacturers filed fewer new drug applications in 2016 and the agency rejected or delayed more applications in 2016 than in 2014 and 2015.

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Some of the delayed drugs, such as Ocrevus, a multiple sclerosis drug from Roche and sarilumab for rheumatoid arthritis from Sanofi and Regeneron, could still win approval in 2017.

Meanwhile, novel drug approvals in 2016 were approved quickly. Thirty-seven percent of the novel drug approvals received fast-track designation, 37% are first in their class and 37% of the new drugs are for rare diseases. And 95% of the novel drugs approved in 2016 were approved in the first review cycle.

Around two-thirds (68%) of novel drug approvals in 2016 were approved under priority review and 32% received breakthrough therapy designation. 

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