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The National Institute for Health and Care Excellence (NICE) has rejected an application by BMS's Zeposia (ozanimod) to treat relapse-difficult multiple sclerosis (RRMS).
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NICE said in an evaluation consultation that while there is evidence that Zeposia can reduce the number of relapses and brain lesions in patients with multiple sclerosis compared to interferon beta-1a, it is not clear how the drug affects disability progression.
nice also said zeposia's cost-benefit estimate was uncertain because of "limitations" in clinical effectiveness evidence.
last May, Zeposia was approved by the European Medicines Agency for treatment with RRMS, and last year it was approved by the U.S. Food and Drug Administration (FDA).
sarah Rawlings, director of research and external affairs at the MS Association, said: "It is disheartening that NICE has decided not to recommend Zeposia for the treatment of MS.
although there are many treatments for this condition, oral drugs are still scarce and people can benefit greatly from a new, more convenient alternative.
decision is not final and we urge them and the manufacturer to review the evidence and consider which method is best for MS patients."