EMA advisory panel recommends Mayzent for secondary progressive multiple sclerosis

pharmafile | November 18, 2019 | News story | Sales and Marketing Europe, Mayzent, Novartis, multiple sclerosis, pharma 

Novartis has revealed that Mayzent (siponimod) has been recommended by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of secondary progressive multiple sclerosis (SPMS), specifically in adult patients with active disease evidenced by relapses or imaging features of inflammatory activity.

The decision was supported by Phase 3 data drawn from 1,651 SPMS patients with varying degrees of disability, as quantified by a score of 3.0 to 6.5 on the Expanded Disability Status Scale. Within the findings, it was shown that Mayzent lowered the risk of disability progression at three and six months by 31% and 37% respectively compared to placebo.

The findings also revealed benefit in cognitive processing speed, and a potential benefit in preserving patient mobility for an average of more than four years.

“Until recently, although we have made considerable strides in reducing relapses and long term disability in patients with relapsing remitting disease, there was little to offer patients who had reached the secondary progressive stage of the disease,” explained Dr Eli Silber, Consultant Neurologist at King’s College Hospital NHS Foundation Trust. “Results from the EXPAND study demonstrate that Mayzent has a positive impact on reducing both cognitive and physical decline, offering renewed hope for people living with active SPMS. The CHMP’s positive recommendation heralds a new era of care for people with active SPMS, potentially offering the multiple sclerosis community, for the first time, a much-needed treatment that is proven to delay disability progression.”

Haseeb Ahmad, Managing Director UK, Ireland and Nordics, Novartis Pharmaceuticals & Country President UK, also remarked on the decision: “At Novartis, we are committed to reimagining care for patients across the MS spectrum, and today’s positive decision marks a significant step towards building a better future for people living with active SPMS. Mayzent offers the potential to expand possibilities for those living with the condition by delaying the progression of disability. We will continue working closely with regulatory bodies to make sure this new treatment is made available in the UK for those who it could benefit.”

The EMA is not bound by the recommendations of the CHMP, but its final decisions frequently mirror the advice of the advisory panel.  

Matt Fellows

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