Merck KGaA has decided to pull a submission for its new multiple sclerosis pill cladribine in Europe, after the regulator required more data.
The European Medicines Agency says it has been formally notified by the firm’s Merck Serono Europe unit of its decision to withdraw an application for a centralised marketing authorisation for cladribine, which would be marketed as Movectro, an oral treatment for relapsing-remitting MS. In September last year, the agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the drug, and on the request of the company, re-examined the case.
However the CHMP confirmed the refusal of the marketing authorisation last month. This rejection has unsurprisingly prompted Merck to withdraw the application, though the German company has told the agency it intends to continue clinical trials with Movectro, which is already approved in Russia and Australia. Pulling the file does not prejudice the possibility of Merck making a new application at a later stage.
The Darmstadt-based group is now waiting to hear from the US Food and Drug Administration, where cladribine has review status. A decision is expected by February 28.
Novartis’ oral MS drug Gilenya (fingolimod) was recommended for approval by the CHMP in January and was approved by the FDA last September.
