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Regulatory Focus™ > News Articles > Flurry of Year-End Drug Approvals Makes 2012 Best Year for Approvals Since 1997

Flurry of Year-End Drug Approvals Makes 2012 Best Year for Approvals Since 1997

Posted 02 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high.

US regulators approved at least seven high-profile and mostly new drug products during the final two weeks of 2012, including:

Varzig (varicella zoster immune globulin preparation) - Cangene Corporation: Approved for reducing the severity of chicken pox infections in high-risk individuals.

Sirturo (bedaquiline) - Janssen Therapeutics: Approved as part of a combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other options have been exhausted. The drug was approved with a boxed warning based on its risks to QT prolongation. In a statement, FDA Commissioner Margaret Hamburg said that the drug's risks were outweighed by the difficulty of treating drug-resistant forms of TB.

Fulyzaq (crofelemer) - PharmaDerm: Approved as a treatment for relieving the symptoms of diarrhea in HIV/AIDS patients, which often occurs as a side-effect to antiretroviral therapies.

Elquis (apixaban) - Bristol-Myers Squibb: The oral, anti-clotting drug is indicated to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation not caused by a heart valve problem.

Juxtapid (lomitapide) - Aegerion Pharmaceuticals: Approved to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH)-all in combination with a low-fat diet and other treatments. The drug is packaged with a Risk Evaluation and Mitigation Strategy (REMS) plan requiring prescriber and pharmacy certification in light of its potential for liver toxicity and potential interactions with other drug products.

Gattex (teduglutide) - NPS Pharmaceuticals: Approved to treat adults with short bowel syndrome who require parenteral nutrition to meet their nutritional needs. The drug's sponsor, NPS, will be required to conduct an additional clinical trial to assess the drug's long-term safety profile.

Tamiflu (oseltamivir) - Roche: While not a new approval, FDA expanded Tamiflu's approval to include children as young as two weeks of age. The approval comes as the drug is under increasing pressure from EU critics, including the British Medical Journal, who allege that Roche has not adequately disclosed data showing the drug is effective, and that they believe the contrary to be true. FDA said the approval was based on an "extrapolation of data from previous study results in adults and older children," as well as pharmacokinetic (PK) studies sponsored by the National Institutes of Health (NIH) and Roche. The drug's approval-late on Friday, 21 December 2012, right before many in the media went on vacation-could be seen by some as a direct attempt by FDA to skirt potential controversy over the approval by burying news of it.

In all, FDA approved 39 new drugs in 2012, taking its approval numbers to a 15-year high, reports Reuters. That number is slightly more optimistic than FDA's fiscal year approvals for 2012 (Based on a 1 October-31 September calendar) that found FDA approved 35 new drugs in 2012-the same number as it did in 2011. By the 1 January-31 December metric, FDA approved just 30 drugs in 2011, a significant increase from the 21 approved in 2010.

The approvals are a relatively high water line for FDA, marking the most it has approved since 1996's unprecedented 53 approvals. Since then, FDA approvals have never achieved even 75% of the success of that year. Since 2000, FDA has only approved more than 30 drugs in a year three times (36 in 2004, 30 in 2011 and 39 in 2012), and the two-year approval total (69) for FDA is the highest since the 1997-1998 years (also tied at 69) and second only to the 1996-1997 total of 92.

Tags: Approvals, 2012, 2011

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