NME approvals up a tic in 2008
The green light for degarelix followed delays in approvals on Takeda's Actos replacement alogliptin – for which the agency set a new target date of June 2009 – and AstraZeneca's Seroquel XR for major depressive disorder, for which FDA issued a complete response letter (nee “approvable letter”) last week.
An Associated Press analysis of agency approvals, published Dec. 19, counted 21 truly novel drugs approved in 2008 – up from 18 in 2004. The approval of degarelix would push it up to 22. Cold comfort for the many manufacturers that saw potentially pivotal drugs delayed as a cautious agency, still shell-shocked from Vioxx and under withering Congressional scrutiny on drug safety issues, demanded further information.
The AP analysis also said the under-resourced agency missed its target review dates for at least 15 drugs, as it did with alogliptin.
After several years of stagnation, the climate for new drug approvals could improve in 2009, with unified Democratic control of Congress and the White House giving the FDA a freer hand and the prospect of a permanent commissioner steering the often rudderless agency.