Takeda febuxostat review delayed
FDA is continuing to review Takeda's febuxostat NDA past the Jan. 18 user fee deadline. Febuxostat is being considered for the treatment of hyperuricemia in patients with gout; an advisory committee recommended approval (12-0 with one abstention) at a Nov. 24 meeting (1"The Pink Sheet," Dec. 1, 2008, p. 5). The committee expressed concern with a potential cardiovascular signal and encouraged FDA to use its post-approval authorities to require further study. FDA also missed the Oct. 24 user fee date for Takeda's alogliptin; that review is now expected to extend until June 2009 (2"The Pink Sheet" DAILY, Dec. 29, 2008)
You may also be interested in...
FDA may be heeding stakeholder calls to set new action dates once an original user fee deadline is missed.
Strong efficacy data and a desperate need for new gout therapies outweigh the potential cardiovascular risk associated with Takeda's febuxostat, an FDA advisory committee determined in recommending approval of the drug during a Nov. 24 meeting
Acoramidis, AstraZeneca/BridgeBio Pharma's investigational treatment for patients with transthyretin amyloid cardiomyopathy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.