Drug Approvals Highest Since 1996

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In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.

The final count is in, and FDA approved 41 drugs in 2014. The number FDA's Margaret Hamburg, MD reported on Dec. 11, 2014-35 new drugs-was six fewer than what was actually approved, indicating the regulatory agency had a busy end to its year. The number represents 14 more new novel medicines than were approved in 2013; it is the second highest tally to the all-time approval high in 1996, when 53 medicines were approved. The European Medicines agency also had a busy year, approving 82 new medications in 2014, up from 79 in 2013 and 57 in 2012, reports Reuters.

According to Reuters, 40% of the new drugs were specialty products for rare conditions. Three of these-Lynparza (olaparib), Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets), and Opdivo (nivolumab)-were among the novel products approved at the tail end of 2014.

It was a big year for Breakthrough Therapies, with FDA approving nine drugs with this designation compared with three in 2013, according to data gleaned by analyst Mark Schoenebaum of Evercore ISI. While five of these were for the treatment of cancer, the other four were for cystic fibrosis, aplastic anemia, and idiopathic pulmonary fibrosis. Schoenebaum said that in general, successful Breakthrough Therapy designation requests showed a reduction in the risk of the event of interest of more than 50%. He wrote in a note that according to FDA documents, “in general, improvements of 10% over comparator do not seem to be [breakthrough therapy] territory.”

Biotech initial public offerings also hit a record high in 2014, as there was much activity with M&A deals in the industry. Following the announcement that Express Scripts would exclusively reimburse Viekira Pak over other high-priced hepatitis C medications, however, the biotech sector had its worst day since April 2014, reportsBloomberg. Although the changes in the market could be reflective of end-of-the-year portfolio cleanups, some fund managers may also be questioning the pricing capabilities of these pharmaceutical companies.


UPDATE: Bernard Munos of Forbes reports that FDA approved a total of 44 drugs in 2014: 39 by CDER and 5 by CBER. He writes, "As usual, this excludes imaging agents (i.e., Lumason and Neuraceq), and only includes the biological drugs from CBER that are of rDNA origin." Of the 44 total approvals, 16 (35%) were biologics, compared with 2013, when only 22% of approved medications were made from living cells.