World MS Day is observed every year on May 30 to help raise awareness, share stories and advocate for early and accurate diagnosis and better care for people with multiple sclerosis (MS).
For 2024 to 2026, worldmsday.org’s campaign theme is diagnosis, under the banner “My MS Diagnosis” and the tagline “navigating MS together.” The campaign focuses on early and accurate diagnosis, barriers to specialist care and the need for stronger health systems that can support people from the first symptoms through long-term disease management.
According to worldmsday.org, worldwide, someone is diagnosed with MS every five minutes.
MS is a chronic immune-mediated disease of the central nervous system, in which the immune system attacks the brain and spinal cord. Symptoms vary widely, but can include vision problems, fatigue, difficulty walking, balance issues, numbness and weakness.
The disease can follow different courses, from relapsing forms marked by periods of symptom flare-ups and recovery, to progressive forms where disability gradually worsens over time.
The public health burden is significant. The Atlas of MS estimates that the number of people living with MS worldwide rose from 2.3 million in 2013 to 2.8 million in 2020 and 2.9 million in 2023, highlighting both rising prevalence and persistent gaps in diagnosis, treatment and care access.
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Why Diagnosis Remains Central to MS Care
MS can be difficult to diagnose because early symptoms may be intermittent, nonspecific or overlap with other neurological conditions.
Delayed diagnosis can delay access to disease-modifying therapies (DMTs), which are designed to target the underlying inflammatory activity of MS, reduce relapses, limit new lesions visible on MRI and slow disability accumulation.
This diagnostic gap also has implications for therapeutic development. As MS treatment becomes more targeted and more competitive, companies are increasingly focused not only on reducing the risk of relapse, but also on progression, convenience, route of administration, pediatric use and biomarkers that can support earlier intervention or better monitoring.
New Multiple Sclerosis Drug Approvals and Treatment Advances
Recent MS approvals and pipeline advances reflect a treatment landscape increasingly focused on earlier intervention, more convenient delivery and therapies that can address both relapsing and progressive disease.
In May 2026, Genentech, a Roche company, received FDA approval of intravenous Ocrevus (ocrelizumab) for relapsing-remitting MS in pediatric patients aged 10 years and older who weigh at least 55 pounds. The approval was based on the OPERETTA II study, in which Ocrevus was noninferior to fingolimod in reducing annualized relapse rate and showed superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions.
The decision is notable because pediatric MS is rare but often highly inflammatory, and treatment options for younger patients have historically been limited compared with the adult MS market. For Roche, the approval also extends the Ocrevus franchise into an age group where high-efficacy therapies could help reshape treatment expectations.
Roche has also been advancing convenience through advances in formulation. In September 2024, the FDA approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab with hyaluronidase, for adults with relapsing forms of MS and primary progressive MS. The treatment is administered as a twice-yearly, 10-minute subcutaneous injection and was supported by the Phase III OCARINA II study, which showed noninferior blood levels compared with IV Ocrevus and consistent disease activity control.
Additional recent activity has also come from the generic market. In January 2026, the FDA approved ScinoPharm’s new generic formulation of glatiramer acetate injection for MS, adding another generic option for an established DMT first approved in the US under the brand name Copaxone in 1996.
BTK Inhibitors Lead the Next Wave of Multiple Sclerosis Drug Development
Among advances in MS treatments, Bruton’s tyrosine kinase (BTK) inhibitors remain one of the most closely watched drug classes in MS. The oral agents are designed to modulate B-cell and myeloid-cell activity, with the goal of addressing both peripheral inflammation and the compartmentalized inflammation believed to contribute to progressive disease.
Roche’s fenebrutinib is currently one of the leading contenders in the space. In April 2026, Genentech reported that fenebrutinib met the primary endpoint in the Phase III FENhance 1 and 2 studies in relapsing MS, reducing annualized relapse rate by 51.1% and 58.5%, in the respective trials, versus teriflunomide over 96 weeks. The company also reported reductions in MRI measures of inflammatory disease activity, with plans to submit the totality of relapsing and primary progressive MS data to regulators.
Roche also reported positive Phase III data in primary progressive MS through the FENtrepid study, where the drug met its primary endpoint of noninferiority versus Ocrevus in reducing disability progression.
If approved, fenebrutinib could become a first-in-class BTK inhibitor in MS and potentially offer a high-efficacy oral option across both relapsing and progressive forms of the disease.
Sanofi’s BTK inhibitor tolebrutinib (brand name Cenrifki) has faced more challenges. In the Phase III HERCULES study, tolebrutinib delayed time to onset of six-month confirmed disability progression by 31% versus placebo in non-relapsing secondary progressive MS. However, the drug did not show superiority over teriflunomide in the GEMINI 1 and 2 relapsing MS trials.
In December 2025, Sanofi said the FDA issued a complete response letter for tolebrutinib in non-relapsing secondary progressive MS, although the drug had been provisionally approved in the United Arab Emirates (UAE) in July 2025 and remained under review in the EU and other jurisdictions.
Other BTK inhibitors continue to move through the pipeline. Novartis is studying remibrutinib (brand name Rhapsido) in Phase III secondary progressive MS, with a randomized, double-blind, placebo-controlled study expected to enroll about 1,275 participants.
InnoCare and Zenas BioPharma are also advancing orelabrutinib, a CNS-penetrant oral BTK inhibitor, in Phase III development for progressive forms of MS, including primary progressive MS and secondary progressive MS.
At the same time, the class has faced setbacks. Merck KGaA’s evobrutinib did not meet the primary endpoints in two Phase III EVOLUTION trials in relapsing MS.
On the diagnostics front, blood-based biomarkers such as neurofilament light chain (NfL), a protein biomarker of axonal damage in the central and peripheral nervous systems, could become increasingly important for monitoring disease activity, supporting treatment decisions and identifying progression earlier.
In its first-quarter 2026 update, Roche highlighted a CE mark for its Elecsys NfL blood test to detect neuroinflammation in MS, describing it as a step forward in disease management.
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