NICE recommends Novartis’ Mayzent on the heels of SMC approval

The National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Mayzent for use by NHS England, only a few days after the Scottish Medicines Consortium (SMC) approved the multiple sclerosis (MS) drug.

Mayzent (siponimod) is licensed to delay disability progression and cognitive decline in secondary progressive multiple sclerosis (SPMS) with active disease.

Following the NICE and SMC recommendations, Mayzent becomes the first oral disease-modifying therapy (DMT) approved for adult patients with SPMS in England, Wales and Scotland.

Approximately 38,000 people in the UK are affected by SPMS, which constitutes over a third of all people living with MS.

Often, the diagnosis of SPMS with active disease is delayed or avoided as a result of uncertainty surrounding when relapsing/remitting multiple sclerosis (RRMS) progresses to SPMS.

This means that many people with SPMS with active disease continue to receive treatment, which is licensed for RRMS and has not been proven effective for treating their disease.

“The decision by both NICE and the SMC represents a significant step forward in ensuring people living with SPMS with active disease in the UK have access to treatment. We are working closely with the NHS to ensure eligible patients can start benefiting from Mayzent as soon as possible,” said Chinmay Bhatt, managing director UK, Ireland & Nordic for Novartis Pharmaceuticals.

Mayzent is a selective small-molecule agonist of sphingosine-1-phosphate (S1P) receptors S1P1 and S1P5.

In the phase III EXPAND study, Mayzent was shown to reduce the risk of three-month confirmed disability progression by a statistically significant 21% versus placebo.

In the SPMS active disease subgroup, results demonstrated that Mayzent reduced the risk of both three- and six-month CPD by 31% respectively versus placebo.