Novartis' Mayzent becomes first drug specifically authorised by FDA for active secondary progressive MS

Novartis announced Wednesday that the FDA approved Mayzent (siponimod) for the treatment of relapsing forms of multiple sclerosis, with the drug becoming the first oral treatment specifically indicated for active secondary progressive MS (SPMS) in adults. The company noted that the selective sphingosine 1-phosphate receptor modulator will be available in the US in around a week's time.

Paul Hudson, head of Novartis' pharmaceuticals unit, said that Mayzent will have a list price of $88 000 per year. Specifically, Mayzent is approved across the MS spectrum for clinically isolated syndrome, relapsing remitting MS and active SPMS. Novartis noted that most patients will not require a first dose observation, unless they have certain pre-existing cardiac conditions.

Approval was based on data from the Phase III EXPAND trial, with results showing that Mayzent significantly reduced the risk of three-month confirmed disability progression in patients with active disease by 21 percent versus placebo. In the study, the drug also reduced the annualised relapse rate by 55 percent.

Analysts predict that Mayzent, which is also under review in Europe, will generate sales of about $800 million by 2022. Stefan Schneider of Bank Vontobel noted that Mayzent is only approved for patients with active SPMS, which represents about 40 percent of the potential market opportunity, while other drugs could be used to treat the phase where they have periods of recovery (for related analysis, see ViewPoints: Mayzent - everything you need to know about Novartis' new multiple sclerosis treatment).

Earlier this month, the Institute for Clinical and Economic Review (ICER) released a draft report assessing the clinical effectiveness and value of Mayzent for SPMS. The ICER suggested that pricing the drug at a similar level to Roche's Ocrevus (ocrelizumab), which has a list price of about $65 000 per year, would put Novartis' medicine "well above commonly cited thresholds for cost effectiveness."

Novartis currently markets Gilenya (fingolimod) for relapsing MS, with the product generating sales of $3.3 billion last year. Meanwhile, Celgene recently submitted a second application to the FDA seeking approval of its oral, sphingosine 1-phosphate receptor modulator ozanimod for the treatment of adults with relapsing forms of MS. For related analysis, see ViewPoints: Celgene's ozanimod regains some momentum but can it deliver in MS?

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