FDA OK’d 27 drugs 2013
US regulators approved 27 new drugs in 2013, a more than 30 percent decline from the 39 therapies that were given the green light the previous year, according to figures released this week by the Food and Drug Administration.
While the number of approvals dropped last year from 2012, which saw a 15-year high, it was closer to the average of 28 new drugs approved in the United States annually over the past five years. Last year’s crop also included two important drugs originating in Massachusetts to treat serious illnesses.
One was Tecfidera, the oral medicine for adults with relapsing forms of multiple sclerosis that has catapulted Cambridge-based drug maker Biogen Idec Inc. to the top ranks of biotechnology companies. The other was Kadcyla, a treatment for women with HER2-positive metastatic breast cancer. That drug is marketed by the Genentech division of Swiss pharmaceutical giant Roche AG, but its cancer-killing technology was developed by ImmunoGen Inc. of Waltham.
Other companies in Massachusetts had a rougher time with the FDA in 2013. The year ended with the agency, citing concerns about safety and clinical trial design, rejecting an MS drug from Genzyme, the Cambridge unit of French drug maker Sanofi SA, that is approved for sale in Europe and Canada.
Earlier, also citing safety data from clinical studies, the FDA rejected a kidney cancer drug developed by Cambridge’s Aveo Pharmaceuticals Inc. and forced another Cambridge company, Ariad Pharmaceuticals Inc., to pull a leukemia therapy from the market only to permit its return seven weeks later.
Last year’s drug approvals included three medicines — a leukemia drug from Roche, a non-Hodgkin’s lymphoma therapy from Johnson & Johnson, and a hepatitis C drug from Gilead Sciences Inc. — designated as “breakthrough therapies” to help speed their time to market.
FDA spokeswoman Stephanie Yao said several factors influence how many drugs the agency approves each year, including the number of applications submitted by drug companies, which can vary from year to year. That number fell to 32 last year from 41 in 2012, according to FDA data.
Denying that the agency has become more conservative or risk averse, John K. Jenkins, director of the office of new drugs at the FDA’s Center for Drug Evaluation and Research said in a presentation last month that the approval rate “has not significantly changed.” He suggested that the 2013 data showed a “regression to the mean” after an outlier year in 2012.
Jenkins said last year’s approvals continued “a strong track record for drug innovation,” including many treatments for rare diseases as well as medicines for more widespread conditions. Nearly three quarters of the novel drugs approved by the FDA last year would be going to market first in the United States, he said.
FDA officials are also working to improve their dealings with drug makers, he said, including “better planning before application submission, submission of complete applications, improved communication and transparency between [the] applicant and review team during review, and additional review time.”