FDA Approves Highest Number of New Drugs Since 2004
12/05/2012| 02:48pm US/Eastern
By Jennifer Corbett Dooren
WASHINGTON--The U.S. Food and Drug Administration has approved the most new drugs in eight years--partly reflecting improvements by the pharmaceutical industry in moving experimental drugs out of company pipelines.
Through the end of November the agency approved 31 new types of drugs, for diseases like cancer, multiple sclerosis, rheumatoid arthritis and HIV, in addition to the first weight-loss drug approved in more than a decade.
The agency still has the rest of the month to add to its total, and has already approved the most new medicines since 2004, when it granted 36 approvals to new drugs. Still, at least one highly anticipated approval expected this year--a new Biogen Idec Inc. (>> Biogen Idec Inc.) MS drug--has been delayed. In October the company announced the FDA needed three more months to review the application for the product, dubbed BG-12. Investors had been hoping for BG-12's approval this month so it could start to compete with another MS drug, Sanofi SA's (SNY, SNY.FR) Aubagio, which was given the green light in September.
The FDA considers new medicines to be those made from new chemicals or proteins that are designed to treat illnesses in different ways than existing treatments. For example, Vivus Inc's (>> VIVUS, Inc.) July approval of its weight-loss drug Qsymia isn't included in the new-drug category because it's a combination of two existing drug ingredients. But the other weight-loss drug approved this year--Arena Pharmaceuticals Inc. (>> Arena Pharmaceuticals, Inc.) Belviq--counts because it contains a new ingredient.
The agency also approves dozens of existing drugs each year for new uses along with approving generic version of brand name products after they lose patent protection.
The agency detailed many of its new 2012 approvals in a separate report released Wednesday, which tallied numbers by the government's fiscal year, which starts Oct. 1. The report took a slightly broader approach to what's considered a new medicine than has traditionally been done by FDA's drug staff. For example, it counted a childhood vaccine that combined components of separate vaccines for meningitis and other bacterial infections. Still the report's figures were mostly similar to the agency's traditional tracking methods and showed 35 new approvals in fiscal year 2012 compared to the same number in fiscal 2011. For calendar year 2011, FDA figures showed 30 new drug approvals compared to 21 in 2010 and 26 in 2009.
The agency said the number of new drugs from small biotech firms was "notable," and included things like Vertex Pharmaceuticals Inc.'s (>> Vertex Pharmaceuticals Incorporated) treatment for a group of cystic fibrosis patients with a specific gene mutation and Xtandi, a prostate cancer drug developed by Medivation Inc. (>> Medivation, Inc.). Big pharmaceuticals companies like Bayer AG (>> Bayer AG (ADR)), Roche Holding AG (RHHBY, ROG.VX), Pfizer Inc. (>> Pfizer Inc.) and Sanofi also had cancer drugs approved this year.
Agency officials have said drug-approval totals often reflect the number of new-drug applications filed by drug companies in the prior year or early in the calendar year. However, the agency only makes its approvals public and is prohibited by law from discussing products it delays or rejects. A standard drug review usually takes 10 months, while a medicine thought to be an advance over an existing treatment can be deemed a priority and given a six-month review.
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