Drug Approvals: An 18-Year High

Making full use of its "breakthrough therapy" accelerated review protocol the US Food and Drug Administration in 2014 approved 51 new therapies, the most in 18 years.

The US Food and Drug Administration approved 51 new therapies in 2014, the highest total of approvals since 1996. The approvals include 41 drugs and 10 biologics, according to a report from Express Scripts.

Part of reason for the surge in approvals was due to the FDA’s using its 2012 guidelines on “breakthrough” therapies. Of the drugs approved in 2014, 9 were breakthrough therapies and their approval took only 4 months compared to the typical 18-month review.

The report also highlighted a few of the breakthrough drugs approved.

Those included 2 for idiopathic pulmonary fibrosis: nintedanib (Ofev/Boehringer Ingelheim) and pirfenidone (Esbriet/InterMune).

They were the first products approved to treat the underlying cause of the disease—as opposed to supportive care, the only other therapy at the time. Many patients with the disease were considered candidates for lung transplantation.

Two breakthrough oncology drugs were also okayed last year on an accelerated review basis. They were ceritinib (Zykadia/Novartis) and idelalisib (Zydelig/Gilead).

Zykadia is for lung cancer patients with a certain type of metastatic non-small cell lung cancer. Zadelig is for relapsed chronic lymphocytic leukemia, follicular lymphoma, and small lymphocytic lymphoma.

Hepatitis C drugs also got quick reviews. In addition to the 2013 approval of sofosbuvir (Sovaldi/Gilead), the FDA in 2014 approved a sofosbuvir/ledipasvir combo (Harvoni/Gilead) and an AbbVie combo called Viekria Pak. The AbbVie product combines ombitasvir, paritaprevir, and ritonavir.

There is a big market for HepC drugs, with 3.2 million people in the US living with the illness, thought there has been controversy over the drugs’ prices.

Diabetes drugs also had a good year, and have an even greater sales potential, since there are 24 million diabetics in the US.

Though they were not classified as breakthrough drugs, 4 new diabetes drugs got FDA approval: dapagliflozin (Farxiga/marketed by AstraZeneca and Bristol-Myers Squibb), empagliflozin (Jardiance/Boehringer Engelhiem), albiglutide (Tanzeum/GlaxoSmithKline)) and dulaglutide (Trulicity/EliLilly).