Novartis' Mayzent EU approval offers SPMS patients new option
Novartis’ Mayzent has been approved in Europe for adults with secondary progressive multiple sclerosis (SPMS) and active disease.
The decision by European regulators means that patients with this form of the disease have a new therapy choice in a situation where options were previously limited.
Secondary progressive disease can occur after the relapsing/remitting stage of the diseases, where patients experience fewer or no relapses but find their disability is increasing.
Novartis said Mayzent (siponimod) addresses an unmet need for SPMS patients with active disease who until now did not have a treatment shown to be effective in delaying progression in this patient population.
In most cases patients would simply continue with their previous medication, chemotherapy, with patients managing symptoms by minimising fatigue, and other strategies such as physiotherapy and cognitive behavioural therapy.
Roche’s infused drug Ocrevus (ocrelizumab) may continue to be used if patients were receiving it for the earlier phase of the disease.
Approval of Mayzent is based on the 779-patient phase 3 EXPAND trial, the largest randomised clinical study in a broad range of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including physical disability and cognitive decline.
In a subgroup of Mayzent-treated patients with active disease, results showed risk of three-month and six-month confirmed disability progression was significantly reduced by 31% and 37% compared with placebo.
Significant favourable outcomes in other relevant measures of MS disease activity, including annualized relapse rate (ARR – confirmed relapses), MRI disease activity and brain volume loss.
Mayzent is the first of a range of drugs in clinical trials for SPMS – in the UK a phase 3 trial funded by the MS Society is assessing simvastatin as a treatment for the condition.
An off-patent drug used to treat high cholesterol, simvastatin is being tested in nearly 30 sites across the UK to see if it slows or stops progression.
AB Science is also testing its masitinib in phase 3, a drug that is also being developed in amyotrophic lateral sclerosis.