FDA: Record Number of Innovative Drug Approvals in 2011

Yesterday the FDA released a report analyzing the "crop" of drug approvals for 2011 - and it's an impressive list. First, the FDA notes that 35 new drugs were approved in 2011, far above the total of 21 in 2010, and the highest total in the last decade except for 2009.

It is certainly an all star list of new medicines:

Seven of the new medicines provide major advances in cancer treatment.

Ten are for rare ("orphan") diseases which have few or no treatments because of their small patient populations.

Two new therapies, for lung cancer and melanoma, are breakthrough products for personalized medicine: each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits.

The agency also notes that 24 (70%) of these medicines were approved first in the U.S., and that half were approved under "priority review", a designation that requires the agency to review the sponsor's application in 6 months or less. All but one of the 35 applications were reviewed before their target date under PDUFA, and the majority were approved "on the first cycle".

The FDA says that this bumper crop reflects

...many improvements in FDA's drug approval process in the last several years. The agency has made great strides forward to speed the development and availability of drugs for serious or life-threatening diseases; it has launched the Critical Path Initiative to help streamline drug testing and review; and it has sharpened its focus on methods of efficiently identifying and resolving drug safety issues.

These results should probably be taken with a grain of salt: they may represent products that have been in development for years (or decades) and thus could easily represent an outlier in terms of new drug approvals. We could be back to fewer new drugs next year, and then 2011 looks like a blip on the radar.

Still, there are clearly some good stories here. Pfizer's Xalkori, for late state lung cancer was approved with a companion diagnostic to target the patients who are most likely to benefit, received an FDA "Fast Track" designation (where the FDA meets frequently with the sponsor), accelerated approval designation (which allowed approval of the drug based on a surrogate endpoint, in this case shrinking tumors), and priority review.

Overall, Xalkori was approved just 5 years after the first human clinical trials - nearly three years shorter than median clinical trial times for oncology drugs. Other important advances this year included the first drug to improve overall survival for late-stage melanoma patients.

Undoubtedly, the FDA is looking for some good press after facing a flurry of critcism from medical device makers and the venture capital community. So kudos to the FDA for a good year in 2011. (At least at first glance).

But the better question is, what are they going to do ensure even better trends for patients and personalized medicines next year, and for the next five or ten years after that? More on that in future posts.

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