FDA's 2013 approvals record falls short of 2012 pace

The good news: The FDA approved 18 new drugs during the first 8 months of this year, including some highly anticipated products on their way to blockbuster stardom--Biogen Idec's ($BIIB) multiple sclerosis drug Tecfidera and Roche's ($RHHBY) new breast cancer drug Kadcyla, to name two.

The not-so-good news, according to Fitch Ratings: The FDA approved 18 new drugs during the first 8 months of this year. Last year, during the same time frame, the agency blessed 22 new drugs. Ergo, this year's total is likely to be lower than 2012's, or so the thinking goes.

Fitch says it has been expecting this slowdown. In May, the ratings agency tallied first-quarter approvals at 12, and concluded that new drug approvals would "moderate" this year. After all, 2012 was a banner year for FDA approvals, with 39 new biopharma products. That's the highest number since 2004. Falling a bit short of that number would be no disgrace.

Still, the year isn't over yet. The FDA's approval pace often increases as the year wanes. The agency is due to decide on a slate of new drugs between now and New Year's Eve, including Gilead Sciences' ($GILD) sofosbuvir, a hep C treatment on FDA's "breakthrough" track; GlaxoSmithKline's ($GSK) lung drug Anoro Ellipta (umeclidinium bromide and vilanterol), recommended by an advisory panel earlier this month; Actelion's ($ATLN) Opsumit (macitentan), a treatment for pulmonary arterial hypertension; and Bayer's Adempas (riociguat), also for PAH.

Then again, the agency has turned away more than a few drug hopefuls this year. Just today, Merck ($MRK) announced a complete response letter for its anesthesia drug sugammadex. Manufacturing problems interfered with Gilead's apps for HIV drugs elvitegravir and cobicistat, both already approved as part of the "quad" pill Stribild. And early this year, the agency dashed Novo Nordisk's ($NVO) hopes for its new diabetes drug Tresiba, asking for new data that will require years to generate.

- see the release from Fitch

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