Regulatory Updates, In Brief

Executive Summary

FDA won't review Merck Serono's oral cladribine NDA: FDA refused to file the NDA for Merck Serono's oral multiple sclerosis drug cladribine, the firm announced Nov. 30. The application was filed in September by the company's U.S. subsidiary EMD Serono (1"The Pink Sheet" DAILY, Sept. 30, 2009). FDA granted the cladribine NDA fast track status based on the need for an oral therapy in the subset of MS patients with relapsing disease. Though Merck Serono was first to submit an NDA for an oral therapy for relapsing MS, it has not been the odds-on favorite for first approval (2IN VIVO, November 2009). At Windhover's FDA/CMS Summit Dec. 3, FDA Office of New Drugs Director John Jenkins spoke generally of the agency's refuse-to-file actions, noting that if industry wants FDA to meet PDUFA review dates, complete applications must be submitted (3The IN VIVO Blog, Dec. 3, 2009)