US Drug approvals in 2012 have reached a 15-year high with regulators giving the thumbs up to 39 new drugs.


The figures from the US Food and Drug Administration show approved drugs were up on 2011, when 30 new medicines were given marketing authorisations. Of the 39 approved in 2012, 11 were for cancer treatments and almost 20 were designated orphan drug status.

Some of the drugs allowed on the US market in 2012 included: Pfizer’s leukaemia drug Bosulif (bosutinib); Ariad Pharmaceutical’s leukaemia drug Iclusig (ponatinib); Johnson & Johnson’s multi-drug resistant TB drug Sirturo (bedaquiline); Roche’s new breast cancer Perjeta (pertuzumab); Pfizer and Bristol-Myers Squibb’s blood thinner Eliquis (apixaban); Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco (ivacaftor); Pfizer rheumatoid arthritis drug Xeljanz (tofacitinib); and Arena Pharmaceuticals Belviq (lorcaserin), the first prescription weight-loss pill in 13 years.

“The sheer number I think supports the correctness in some of the strategy shift of the pharmaceutical companies over the last number of years,” Rick Edmunds, a senior partner at Booz & Co, told Bloomberg. The increase is suggestive of the future growth potential of the industry, he added.

The Pharmaceutical Research and Manufacturers of America also agreed, adding that the increase highlights the innovation within the industry.

Legislation to renew the Prescription Drug User Fee Act is also believed to have improved the quality and timeliness of drug approvals including accelerated approval paths for drugs treating rare diseases.

Over the past decade the number of approvals has dropped, averaging about 23 a year, after revelations over the safety of Merck’s painkiller Vioxx in 2004 saw more caution from the FDA and requests for more safety data. The highest number of drugs approved by the FDA was in 1996 when 53 made it through.        

Analysts expect 35 new drugs to be approved in 2013.