MS drug market heats up as FDA backs Novartis' new pill


The FDA has approved Novartis’ Mayzent (siponimod) multiple sclerosis pill for relapsing forms of the disease, dealing a potential blow to a much-delayed rival from Celgene.

Mayzent’s approval comes hot on the heels of Celgene’s delayed filing for its MS drug ozanimod, which should have been reviewed by the FDA by now had it not been for a botched filing early last year.

The FDA approved Mayzent (siponimod) for adults with relapsing forms of the disease, including secondary progressive multiple sclerosis (SPMS), with active disease, relapsing remitting multiple sclerosis (RRMS) with active disease, and relapsing remitting MS (RRMS) and clinically isolated syndrome (CIS).

SPMS is a debilitating form of multiple sclerosis (MS) characterised by progressive and irreversible neurological disability. Mayzent is expected to be available in the US in about one week.

Priced at $88,000 per year, Mayzent is the first oral drug to treat secondary progressive MS, and also poses a threat to Roche’s new blockbuster Ocrevus (ocrelizumab), a twice-yearly infusion that also covers relapsing remitting disease including SPMS.

Also in Novartis’ sights is Biogen and its Tecfidera (dimethyl fumarate), which has produced strong sales over the last few years, but can produce unpleasant gastrointestinal side-effects.

Most patients transition from RRMS to SPMS over time. Therefore, starting therapy early is critical for patients to help slow the rate of disability progression.

Disability progression most frequently includes - but is not limited to - an impact on ambulation, which could lead to patients needing a walking aid or a wheelchair, bladder dysfunction and cognitive decline.

Mayzent significantly reduces the risk of disability progression, measured after three months, by 21% compared with placebo in a group of SPMS patients who had been living with the disease for around 16 years.

Patients will not require a first dose cardiac monitoring observation unless they have a pre-existing heart condition.

Novartis has also filed Mayzent with European regulators and expects a decision in late 2019.

The Swiss company expects further regulatory decisions in Switzerland, Japan, Australia and Canada this year.