The year 2012 was a banner year for drug approvals in the United States. And, now that the final count is in for 2013, the pharmaceutical industry’s R&D efforts fared very well in 2013, also.
According to a Bloomberg report this week, the FDA approved 27 “new,” or novel, drugs last year, a decline from the 39 new NMEs that were approved in 2012, but still a sizable number of new drugs compared with the approval rates of previous years this century.
Among the most significant approvals in 2013, the new hepatitis C pill Sovaldi (developed by Gilead Sciences) is expected to reduce the treatment regiment by about half and may achieve sales of $2.5 billion in 2014. The new drug moved through the FDA approval process under the “breakthrough therapy” designation.
Michael Yee, an analyst with RBC Capital Markets in San Francisco, told the news service that the high approval rate reflects increased effort to provide pharma companies better access to FDA staff who play a key role in shepherding new products through reviews. (Read the Bloomberg report here.)
“That makes Wall Street generally feel good, that the FDA pendulum is swinging more in terms of accommodation,” Yee told Bloomberg. “That doesn’t mean FDA has lowered the hurdle. The FDA is being more collaborative, more accommodating, rather than being an antagonist.”
According to the Bloomberg report, the FDA’s approval of new molecular entities (NMEs) has averaged about 23 per year over a decade and 28 over the past five years. “Approvals fell in 2013 partly because of a drop in applications,” Bloomgerg reported. “The agency received 32 requests for clearance as of Dec. 11, down from 41 in 2012.”
The FDA last year also approved Invokana (developed by Johnson & Johnson’s Janssen unit), the first drug in a new class of treatments for Type 2 diabetes; Gazyva (developed by Roche), another “breakthrough” therapy to treat chronic lymphocytic leukemia, a blood and bone marrow disease, and Imbruvica (developed by J&J and Pharmacyclics) to treat mantle cell lymphoma, according to the Bloomberg report.