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NICE knocks back Novartis' Mayzent in secondary progressive multiple sclerosis over data gaps

Published on 25/06/20 at 11:54am

Novartis’ Mayzent (siponimod) has been unsuccessful in securing a recommendation from NICE for use on the NHS for the treatment of secondary progressive multiple sclerosis (MS), a condition which affects around 9,000 people in England.

The indication related specifically to adult patients showing evidence of active disease, meaning they are prone to relapses or whose disease displays inflammatory activity.

In clinical trials, the therapy showed benefit in slowing progression of disease and reducing the number of relapses compared to placebo, but available data did not make any direct comparisons to interferon beta-1b, the only currently available disease-modifying therapy in secondary progressive MS.

As a result, the NICE committee was not able to determine how Novartis’ treatment stacked up against interferon beta-1b, and so couldn’t move to recommend the use of the drug on the NHS. Thus, NICE rejected the drug but requested further data from Novartis, specifically efficacy data comparing Mayzent directly with best supportive care.

“We know there are currently few, if any treatments available for people with this form of MS, and that siponimod is a promising drug that has the potential to address this unmet clinical need,” commented Meindert Boysen, Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at NICE. “We are, therefore, committed to working with the company to help them address the issues identified by the committee that are highlighted in this draft guidance.”

Matt Fellows

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