New drug approvals took a nosedive in 2016. Here are the 22 that made the grade


As the saying goes, what goes up must come down, and to the biopharma industry's chagrin, that’s exactly what happened to new drug approvals in 2016. Last year, the FDA logged 22 new drug OKs, a paltry total compared with the 45 that won a green light in 2015 and 41 in 2014.

A slowdown in applications was partly to blame: the FDA received 36 applications for new molecular entities in 2016, down from 40 in 2015 and 41 the previous year. But the disappointing fact is that the FDA delayed or rejected far more new drug apps last year than in 2015.

As of Dec. 9, the agency had issued 12 complete response letters in 2016, compared with just two in 2015. Not since 2013 has the FDA turned back or put off so many new products. And several of those CRLs stemmed not from problems with clinical data, but manufacturing.

The FDA's new, speedier approval pathways also eroded 2016's numbers. Multiple drugs due for a decision in 2016 sneaked into 2015, thanks to accelerated approvals.

Is 2016's poor showing a bad sign for future approvals? Analysts are split on that question. Leerink Partners’ Geoffrey Porges and Evercore ISI Group’s Umer Raffat figure that the downturn last year can’t be extrapolated, while EvaluatePharma forecast new drug approvals to be down in 2017 as well.

Merck, AbbVie and Eli Lilly led the pack in 2016, with two approvals each. At the other end of the spectrum, some major players went without in 2016, notably AstraZeneca, whose hyperkalemia candidate suffered a CRL, and Novartis, which won big in 2015 with four approvals. Here's the full list of new molecular entities that earned FDA approval in 2016.

-- Amirah Al Idrus

New drug approvals took a nosedive in 2016. Here are the 22 that made the grade

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