FDA ends year with 39 approvals

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Although Congress ended 2012 with a headline-grabbing standoff, the final FDA approval tally shows that legislative gridlock did not halt everything inside the Beltway.

Included among the end-of-year approvals was the December 28 green light of Janssen's Sirturo, for treatment-resistant TB. The drug was given priority review, an option the agency has used to usher in many of the 39 new medical entities it approved during the calendar year. Also among then last minute approvals were Bristol-Myers Squibb's blood thinner Eliquis and Salix Pharmaceutical's Fulyzaq, an anti-diarrheal  for HIV/AIDS patients.The Salix nod was a two-for-one—it was not only the first for this patient population, but it was also the second botanical prescription drug the regulator has approved (the first was in 2006, when it gave the nod to PharmaDerm's genital wart treatment, Veregen).

he final tally was actually the latest of several revisions, including a December 10 agency presentation which said the regulator had approved 31 NMEs, only to be revised to 35 soon after. The regulator attributed the quickened pace partly to greater experience with tools like REMS and a drop in what it called “'me-too' submissions for chronic symptomatic diseases” that also had a less favorable risk/benefit profile in its December 10 presentation.

Spokesperson Sandy Walsh told MM&M the agency can only review what comes across its desk. Variations in the rate of submissions can make year-over-year comparisons tricky, but the regulator placed 39 new drugs in the ready-to-market category this year—up from 2011's 30, which included Regeneron's Eylea and AstraZeneca's Brilinta.

Although grumbling about the pace of FDA approvals remains a constant within the industry, the agency has drawn accolades of late. In addition to the Government Accountability Office which noted in May that the FDA was on track to hit its PDUFA targets, Wayne Pines, president of healthcare and regulatory services at APCO Worldwide, told MM&M that the regulator has established measures that help it keep pace with pipeline output. “PDUFA deadlines have made the process more efficient and predictable," said Pines. "FDA is often accused of being a major obstacle in the drug development process, but I don't think it is. Good drugs based on sound data will be approved efficiently."

In addition to channels like Fast Track and Priority Review which allow the regulator to speed certain pipeline drugs through the process, the agency enters 2013 with the additional power of the Food and Drug Administration Safety and Innovation Act, passed this summer. The law confers a “breakthrough therapy” label to drugs that may treat a serious or life-threatening condition based on preliminary clinical evidence. The agency granted two Breakthrough Therapy labels for 2012 as of December 10, and denied one. The agency's December 10 report also noted that it closed the year with an all-time high of New Molecular Entity first-cycle approval rates.

“What's most important is that from the patient's standpoint, 2012 was a good year. A lot of good new drugs were approved,” Pines said.
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