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WSJ – FDA Drug Approvals Increase

WSJ – FDA Drug Approvals Increase


The Food and Drug Administration is on track to approve more than 30 new drugs this year—the most in eight years—partly because the pharmaceutical industry is speeding development of experimental drugs.


As of the end of November, the agency approved 31 new types of drugs for diseases including cancer, multiple sclerosis, rheumatoid arthritis and HIV in addition to the first weight-loss drug approved in more than a decade. A separate FDA report released Wednesday also said that, based on a broader definition of what counts as a new drug, the agency showed 35 new approvals in the fiscal year that ended Sept. 30.

The agency still has weeks to add to its calendar year total, but has already approved the most new medicines since 2004, when it approved 36 new drugs.

At least one highly anticipated approval expected this year—a new Biogen Idec Inc. MS drug—has been delayed. In October, the company announced that 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. It would compete with another MS drug, Sanofi SA’s 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 July approval of its weight-loss drug Qsymia isn’t included in the new-drug category because it is a combination of two existing drug ingredients. But the other weight-loss drug approved this year—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 FDA said the number of new drugs approved from small biotech companies was “notable,” and included Vertex Pharmaceuticals Inc.’s treatment for a group of cystic fibrosis patients with a specific gene mutation, and Xtandi, a prostate cancer drug developed by Medivation Inc.

Big companies such as Bayer AG, Roche Holding AG, 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. Only approvals are made public; the agency is prohibited by law from discussing products it delays or rejects. A standard drug review usually takes 10 months, although a medicine thought to be an advance over an existing treatment can get an expedited six-month review.