Multiple Sclerosis: Large market with unmet need

Current treatment options available (major therapeutics classes approved include interferons, S1p modulators, and antibodies against integrins, CD20 or CD52) are limited for progressive MS treatment. Roche’s Ocrevus (anti-CD20) is the only drug approved for the PPMS patients​.

Ocrevus is also approved for RMS treatment and is currently leading the MS market with $6B of sales in FY2022​.

Despite the increasing number of high-efficacy therapies over recent years, there is still a need for new agents with novel mechanisms that are safer, efficacious, convenient, and well-tolerated. Current drugs are associated with substantial adverse events such as progressive multifocal leukoencephalopathy, hepatotoxicity, seizures, or herpes infections​.

Novel therapies under development, such as Bruton’s tyrosine kinase (BTK) inhibitors (Ph3 assets like Sanofi’s tolebrutinib, Novartis’ remirutinib, and Merck’s evobrutinib, etc.) or CAR-T cells, are able to penetrate the brain and tackle central mechanisms of MS:

• BTKi has the potential to replace existing oral therapies on efficacy benefit. BTKi could compete with Ocrevus in the treatment of PPMS; In RMS treatment, BTKi may be positioned as an add-on/frontline therapy to anti-CD20 therapy​
• Roche aims to maintain leadership in the MS market with the development of a new BTK inhibitor (fenebrutinib) for RMS and PPMS, in addition to seeking supplemental approval for Ocrevus subcutaneous dosing (expected by 2H24) and high dose formulation (filing expected in 2025)​

What potential future Multiple Sclerosis advances are you most excited about?

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