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FDA approves Novartis' next-gen MS drug Mayzent

Drug reduces risk of disease progression

Novartis

Novartis’ Mayzent has been approved in the US, where it will be the first drug to treat disease progression in patients with an advanced form of multiple sclerosis.

The drug is the first treatment specifically approved for patients with active secondary progressive multiple sclerosis (SPMS) in over 15 years, and its oral formulation is also a first for this variant of the disease, which around 80% of relapsing and remitting MS patients go on to develop.

SPMS is usually characterised by an irreversible decline of neurological functions, and according to Novartis, there remains a high unmet need for safe and effective treatments to help delay the disability progression in SPMS.

“One of the most important aims of MS treatment is delaying disability progression and preserving cognition,” said Paul Hudson, head of Novartis' pharma division.

“With Mayzent, SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity.”

The FDA approved the drug based on the phase 3 EXPAND study, which compared the efficacy and safety of Mayzent versus placebo in patients with SPMS.

Novartis' pivotal trials confirmed that Mayzent significantly reduced the risk of disease progression, including physical disability and cognitive decline.

The drug, which is expected to be available to US patients with SPMS very soon. It is part of a new class of S1P-receptor modulators that are safer and more effective than the first generation drugs, such as Novartis’ top-earner Gilenya, which brought in over $3.34bn last year.

Analysts predict Mayzent will hit peak sales of up to $3bn, but will have to battle hard with competitors such as Roche's MS star drug Ocrevus.  It is used in both relapsing forms of MS and primary progressive MS, and is priced at around $65,000 per year.

Mayzent will be priced slightly higher than Ocrevus at $88,000 per year, but according to an ICER report the cost per additional QALY for the drug would exceed usual thresholds for cost effectiveness.

The approval comes just one day after Celgene its MS treatment, ozanimod, which is likely to be a close rival to Novartis' drug once approved.

27th March 2019

From: Regulatory

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