FDA Approved 41 New Drugs in 2014, Most in Nearly Two Decades

The FDA approved seven new drugs last month, pushing its total to 41 last year, the highest number of new molecular entities cleared by the agency since 1996.

CDER already was touting 2014 as a strong period for approvals in early December when it celebrated 35 approvals of NDAs and BLAs up to that point. In particular, the FDA cited 2014 as the best year ever for approvals of drugs with a rare disease indication.

The 41 total approvals, including those for cancer, infectious diseases, diabetes and hepatitis C, represent more than a 50-percent increase over the 27 drugs the FDA approved in 2013. It also beats out the 39 NMEs approved in 2012. The FDA hasn’t approved more drugs since it signed off on 53 therapies in 1996.

Key among 2014’s approvals were therapies to treat hepatitis C, including Gilead’s Harvoni (ledipasvir and sofosbuvir) and AbbVie’s Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets).

Of the total approvals, 11 were cleared under the FDA’s breakthrough therapy designation, which played an increasing role in the approval process, according to Friends of Cancer Research. Such drugs included those for cancer, infectious diseases and rare inherited disorders, the group said.

Specialty drugs and those that treat rare diseases are likely to continue as driving factors behind pharmaceutical growth in the years ahead, the American Pharmacists Association said.

See the full list of drugs approved in 2014 here: www.fdanews.com/01-02-15-Drug-Approvals-2014.pdf. — Bryan Koenig