FDA approvals of innovative drugs up for FY2011

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FDA green-lighted a bumper crop of new medicines in fiscal year 2011, thanks to expedited approval authorities, flexibility in clinical trial requirements and PDUFA measures aimed at boosting approvals of innovative compounds, the agency said.

FDA approved 35 new medicines over the course of the fiscal year, which ended September 30, delivering the agency's second-biggest lot of innovative drugs in the past decade, bested only by 2009's 37. Approvals included breakthroughs in personalized medicine for melanoma and lung cancer, two new treatments for hepatitis C, a drug for late-stage prostate cancer, the first new drug for Hodgkin's lymphoma in 30 years and the first new drug for lupus in 50 years. Seven of the drugs represent major advances in cancer treatment, said the agency, while ten are for rare or orphan diseases and almost half were found to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection.

FDA noted in its report, FY 2011 Innovative Drug Approvals, that 24 of the new medicines were first approved in the US, and asserted that the numbers show it is delivering on increased PDUFA fees, which went up in 2007.

“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and the FDA, and we continue to use every resource possible to get new treatments to patients,” said FDA commissioner Margaret Hamburg, MD. “We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st Century.”

PhRMA SVP scientific and regulatory affairs Dr. David Wheadon hailed the news in a statement, saying the tally “demonstrates the shared commitment of biopharmaceutical research companies and the agency to medical progress and patient care."

“By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs," said Wheadon. "Of course, the tremendous value of these advances – and FDA's review and approval of them – underscores the importance of expedient approval of a clean Prescription Drug User Fee Act, which will help provide the resources needed to allow FDA to continue to serve, and enhance, its essential function.”
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