Merck Serono Submits Oral Cladribine But That Doesn't End The Oral MS Race
This article was originally published in The Pink Sheet Daily
Executive Summary
Merck Serono's NDA filing will not prohibit a possible priority review for Novartis' oral FTY720, which had Phase III data released the same day; both applications face close scrutiny with less than ideal clinical trial packages.
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Novartis Holds Lead In Oral MS Space With Fingolimod Filing
Novartis has gained the lead in the race to market for the first oral therapy for multiple sclerosis with the NDA submission for fingolimod, a feat made possible by FDA's refusal to file the earlier NDA for Merck Serono's oral MS candidate cladribine
Novartis Holds Lead In Oral MS Space With Fingolimod Filing
Novartis has gained the lead in the race to market for the first oral therapy for multiple sclerosis with the NDA submission for fingolimod, a feat made possible by FDA's refusal to file the earlier NDA for Merck Serono's oral MS candidate cladribine
Regulatory Updates, In Brief
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)