Multiple sclerosis battle hots up as FDA approves drugs from Novartis, Merck KGaA

By PharmaCompass

2019-04-04

Impressions: 69 Article

It was a big week for the fight against multiple sclerosis (MS), a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communications between the brain and other parts of the body. First, Merck KGaA bagged FDA approval for its oral MS treatment Mavenclad (cladribine) as the first and only oral short-course treatment for relapsing-remitting and active secondary progressive forms of the disease.

This is particularly significant as the drug returned from the dead after receiving a complete response letter (which determines that the agency will not approve the application or abbreviated application in its present form) from the FDA eight years back. The German drugmaker worked on its clinical progress through these years and has now successfully bounced back into the MS battleground.

According to the FDA statement, cladribine is not recommended for MS patients with clinically isolated syndrome – the first episode of neurologic symptoms lasting at least 24 hours caused by inflammation or demyelination in the central nervous system. Merck is yet to announce Mavenclad’s US launch date and pricing details.

Second, Novartis bagged a fresh approval for Mayzent (siponimod) last week. Mayzent is approved for various forms of MS, including clinically isolated syndrome. It is expected to be launched in the US as early as this month.

The Swiss drugmaker has announced its list price at US$ 88,500 annually, which according to a BloombergQuint report, is 7.4 percent less than its previously launched MS drug, Gilenya (fingolimod).

Novartis’ Gilenya has been leading the MS field with US$ 3.34 billion in annual sales, followed by Roche’s Ocrevus that generated US$ 2.4 billion in 2018 sales.

Meanwhile, Celgene is also looking to break ground in this segment with ozanimod for which it refiled its New Drug Application with the FDA last week for the treatment of adults with relapsing forms of MS (RMS).

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