FDA Approves Mayzent, Next Generation Novartis MS Drug

Novartis Mayzent has been approved in the United States. It will be the first drug to treat the progression of the disease in patients with advanced forms of multiple sclerosis.

The drug is the first treatment specifically approved for patients with secondary active progressive multiple sclerosis (SPMS) for more than 15 years, and its oral formulation is also a first for this variant of the disease, used by approximately 80% of patients with relapsing or relapsing multiple sclerosis. to develop.

MSPS is generally characterized by an irreversible decline in neurological function and, according to Novartis, there remains a significant unmet need for safe and effective treatments to help delay the progression of disability in MSPS.

"One of the most important goals of treating multiple sclerosis is to delay the progression of disability and preserve cognition," said Paul Hudson, head of Novartis' pharma division.

"With Mayzent, SPMS patients with active disease will have access to the first effective oral treatment geared toward disease progression, even as MS progresses to a stage where deterioration is less dependent on habitual relapse activity." "

The FDA has approved the drug based on the EXPAND Phase 3 study, which compared the efficacy and safety of Mayzent to a 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 should be available very soon for US patients with SPMS. It's part of a new clbad of S1P receptor modulators, safer and more efficient than first-generation drugs, such as Gilenya, Novartis' biggest support, which has raised more than $ 3.34 billion. 'last year.

Analysts expect Mayzent to reach $ 3 billion, but will have to battle with competitors such as Roche's flagship drug, Ocrevus. It is used in both recurrent forms of MS and in primary progressive MS and its price is about $ 65,000 per year.

The Mayzent price will be slightly higher than that of Ocrevus, at $ 88,000 a year, but according to an ICER report, the cost per additional QALY of the drug would exceed the usual profitability thresholds.

This approval comes just one day after treatment by Celgene, the ozanimod, who will likely be a serious competitor of the Novartis drug once approved.

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