Magazine article Drug Topics

FDA Approvals Topped 39 in 2012

Magazine article Drug Topics

FDA Approvals Topped 39 in 2012

Article excerpt


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 anti diarrheal drug for HIV/ AID S 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. …

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