FDA drug approvals hit record high

February 12, 2013

FDA approved 39 innovative drug therapies in 2012, the most new drug approvals in the U.S. since 1996.

In 2012, the U.S. Food and Drug Administration (FDA) approved 39 innovative drug therapies-the most new drug approvals in the United States since 1996, when 53 new drugs were approved. In 2011, FDA approved 30 new drugs.

Eight of the 2012 approvals came in December. Two approvals came just before the new year: bedaquiline, the first drug to treat multidrug-resistant tuberculosis; as well as crofelemer, the first anti-diarrheal drug for HIV/AIDS patients.

Also noteworthy was the approval of apixaban, an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. A novel drug that was specifically designed to treat a rare form of cystic fibrosis and advanced basal cell carcinoma also received approval.

“From the 39 novel drugs, the United States was the forerunner in terms of giving approval to 75% of these drug therapies before they were made available in other countries,” says Abimbola Farinde, PharmD, clinical staff pharmacist at Clear Lake Regional Medical Center in Webster, Texas. “It is the firm belief of FDA that Americans should be able to have access to drug therapies that are both safe and effective, which also could have provided the momentum that led to the approval of these novel drugs, in particular for difficult-to-treat disease states.”

With the review of the new therapeutic drug classes that have received FDA approval, Dr. Farinde says that she is looking forward to the release of 10 drugs that will be indicated to treat various forms of cancer including late-stage colorectal cancer, prostate cancer and myelofibrosis.

Industry watchers are anticipating the approval of asparaginase Erwinia chrysthemi (Erwinaze) for the treatment of acute lymphoblastic leukemia (ALL), which affects approximately 6,000 Americans, 60% of whom are children. ALL is the most common form of childhood cancer, with the peak incidence between age two and five.

“It is my expectation that Erwinaze will follow on the heels of the other cancer agents to offer an alternative for the treatment of ALL,” says Dr. Farinde. “The upcoming year will set the stage for greater drug variety and the availability of more therapeutic options to choose from when treating  patients with diseases that are both rare or not rare.”