New Drug Approvals Soar In 2014

In an encouraging sign of the health of the pharmaceutical industry, new drug approvals soared to an 18-year high in 2014. The Food & Drug Administration gave the green light to 41 new molecular entities last year, up from 27 in 2013.

In years past, a surge in new approvals often meant a flood of me-too drugs had made it onto the market. But the 2014 class of new drugs is ripe with innovation: The list includes 16 first-in-class treatments, compared with just nine drugs with a novel mechanism of action approved in 2013.

Last year was the best year ever for rare disease drug approvals, FDA said, with orphan drugs accounting for roughly 40% of the new drugs approved. Other highlights included 12 new treatments for infectious diseases, including four much-needed new antibiotics. And eight new cancer drugs hit the market, a crop that included several immunotherapies that represent major advances for patients.

FDA crammed seven of those new drug approvals into the last month of the year. The final push included several key products: Amgen’s bispecific antibody Blincyto, for the treatment of a type of leukemia; AbbVie’s Viekira Pak, a combination of antivirals for the treatment of hepatitis C; and Bristol-Myers Squibb’s melanoma immunotherapy Opdivo.