FDA approvals topped 39 in 2012

In 2012, FDA achieved a milestone and made groundbreaking strides with the approval of 39 innovative and cutting-edge drug therapies for populations in need.

Almost a record

Last year saw 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 (Sirturo, Janssen Therapeutics, a division of Janssen Products), the first drug to treat multidrug-resistant tuberculosis, was approved, as was crofelemer (Fulyzaq, Salix Pharmaceuticals, under license from Napo Pharmaceuticals), the first antidiarrheal drug for HIV/AIDS patients taking antiretroviral therapy.

Also noteworthy was the approval of apixaban (Eliquis, Bristol-Myers Squibb and Pfizer), an oral tablet used to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that is not caused by a heart-valve problem. Also among the novel drugs that were approved was a drug specifically designed to treat a rare form of cystic fibrosis and advanced basal cell carcinoma.

A convergence of factors

“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,” said Abimbola Farinde, PharmD, clinical staff pharmacist at Clear Lake Regional Medical Center in Webster, Texas.

“The desire to increase the accessibility of more life-saving drugs to the general public appears to be the driving force behind this increase in drug approval,” said Farinde.

“It is the firm belief of FDA that Americans should be able to have access to drug therapies that are both safe and effective,” she continued, “which also could have provided the momentum that leads to the approval of these novel drugs, in particular for difficult-to-treat disease states.

“Additionally, these approvals were made possible through the expedited review, as well as allowing drug companies to conduct shorter, fewer, and smaller studies, which still had to adhere to high-quality standards that FDA has put into place with regard to the performance of clinical drug trials,” she said.

Active communication between FDA and the drug companies responsible for the development of some of these novel drug therapies enabled more efficient reviews, Farinde added.

“These reviews came in the form of fast-track, priority review, and accelerate approval or flexible clinical development programs, and if issues are identified, these are addressed early on, so as to not delay the review process, but rather allow for better streamlining,” she said.

Different cancer treatments

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

“The availability of these drugs will offer additional agents on the market that may help to optimize cancer treatment and potentially increase the probability of achieving better outcomes,” she said.

Industry watchers are anticipating the approval of asparaginase erwinia chrysthemi (Erwinaze, EUSA Pharma, an International Division of Jazz Pharmaceuticals) 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 a peak incidence occurring between the ages of two and five years.

“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,” said 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.”

- Tracey Walker, Contributing Editor