Latest MS drugs approved in 2025–2026: Cenrifki (tolebrutinib), pediatric Ocrevus, generic glatiramer and what is next
A round-up of the newest MS approvals: EU greenlights Cenrifki (tolebrutinib) — the first disability-targeting drug for non-relapsing secondary progressive MS — FDA expands Ocrevus to children 10+, a new generic glatiramer arrives, and we explain what each one means for patients and for Serbia.
The news in one paragraph
I am writing this from a personal angle too: I have lived with MS for years, and I know how much a calm explanation matters. The past 12 months have brought the biggest shake-up of the MS drug landscape since the arrival of ocrelizumab. The European Commission has approved Cenrifki (tolebrutinib) as the first medicine ever indicated specifically for non-relapsing secondary progressive MS (nrSPMS) — a population that until now had no approved therapy at all ([Sanofi press release, 23 June 2026](https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-23-05-00-00-3315699); [MS News Today, 24 June 2026](https://multiplesclerosisnewstoday.com/news-posts/2026/06/23/eu-regulators-approve-tolebrutinib-now-cenrifki-treat-nonrelapsing-spms/)). The FDA has expanded Ocrevus (ocrelizumab) to children aged 10 and older with relapsing-remitting MS ([Genentech, 8 May 2026](https://www.gene.com/media/statements/ps_050826)). And a new generic glatiramer acetate injection has reached US pharmacies in January 2026, cutting the cost of one of the oldest DMTs ([NeurologyLive, Jan 2026](https://www.neurologylive.com/view/fda-approves-generic-glatiramer-acetate-injection-multiple-sclerosis-treatment)). Below — what each approval actually means.
Cenrifki (tolebrutinib) — EU approval, June 23, 2026
What it is
Cenrifki is the brand name for tolebrutinib, a brain-penetrant Bruton tyrosine kinase (BTK) inhibitor developed by Sanofi. Unlike existing MS therapies that mainly suppress new inflammation from outside the central nervous system, tolebrutinib crosses the blood-brain barrier and acts directly on microglia and B cells *inside* the brain — the cells believed to drive the slow, "smoldering" neurodegeneration that defines progressive MS ([Sanofi pipeline page](https://www.sanofi.com/en/our-science/our-pipeline)).
What it is approved for
The European Commission approved Cenrifki on 23 June 2026 for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS) — patients whose disease has shifted into a steady, gradual disability progression without acute relapses. This is the first drug ever approved specifically for this group in the EU, who previously had no DMT option at all ([European Commission decision, June 2026](https://ec.europa.eu/health/documents/community-register/html/h1882.htm)). Approval is based on the HERCULES phase 3 trial, which showed that tolebrutinib delayed confirmed disability progression by 31% versus placebo over the study period, with supporting evidence from the GEMINI 1 and 2 trials in relapsing MS ([HERCULES — NEJM 2024](https://www.nejm.org/doi/full/10.1056/NEJMoa2407625); [Sanofi HERCULES results](https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-20-13-30-00-2950789)).
How it is dosed
Cenrifki is an oral once-daily tablet (60 mg) — a major practical advantage over infusions like ocrelizumab or natalizumab.
Safety — the part that matters
Liver enzyme elevations are the most important safety signal. During HERCULES, a small number of participants had significant transaminase rises; the EU label requires weekly liver function tests for the first 12 weeks of therapy. People with active liver disease or severe hepatic impairment should not take Cenrifki. The benefit-risk profile was judged favorable specifically because nrSPMS patients otherwise have no treatment options ([EMA EPAR — Cenrifki](https://www.ema.europa.eu/en/medicines/human/EPAR/cenrifki)).
The FDA story — denied for now
In December 2025 the FDA issued a Complete Response Letter, declining to approve tolebrutinib for nrSPMS in the United States ([Sanofi update, 24 Dec 2025](https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-24-06-00-00-3210238); [MS News Today, 29 Dec 2025](https://multiplesclerosisnewstoday.com/news-posts/2025/12/29/fda-denies-tolebrutinib-approval-nonrelapsing-progressive-ms/); [FDA CRL document](https://download.open.fda.gov/crl/CRL_NDA219624_20251223.pdf)). The agency asked for additional analyses around the liver safety signal. Sanofi is in active discussions with the FDA to find a path forward and is continuing the phase 3 PERSEUS trial in primary progressive MS — results expected later in 2026.
Why this matters for the field
For 25 years, the "progressive MS without relapses" group has been the great unmet need. Ocrelizumab is approved in primary progressive MS but the effect on pure progression is modest. Cenrifki is the first molecule whose primary effect is slowing the progressive part of MS itself, not the relapses. If long-term data confirm the benefit, it will redefine what we treat in MS.
Ocrevus (ocrelizumab) approved for children — FDA, 8 May 2026
What changed
On 8 May 2026 the FDA expanded the Ocrevus label to include children and adolescents 10 years of age and older with relapsing-remitting MS ([Genentech statement](https://www.gene.com/media/statements/ps_050826)). Until this approval, no high-efficacy B-cell therapy was officially indicated for pediatric MS — children and teens often received fingolimod (approved for ≥10 years) or off-label adult DMTs.
Why it matters
Pediatric MS is rare but particularly aggressive — children typically have 2–3× higher relapse rates than adults and accumulate brain lesions faster ([Chitnis T et al., Mult Scler 2020](https://journals.sagepub.com/doi/10.1177/1352458520901713)). Having a high-efficacy infused DMT (every 6 months) with an established adult safety record gives pediatric neurologists a long-awaited tool and brings care closer to the "early, hard hit" principle now standard in adult MS.
How it works
Ocrelizumab is a monoclonal antibody that depletes CD20+ B cells, given as an IV infusion every 6 months. The pediatric approval was based on a phase 3 study in adolescents showing efficacy and safety consistent with the adult experience.
Generic glatiramer acetate — FDA, January 2026
What changed
In January 2026 the FDA approved a new generic glatiramer acetate injection (20 mg/mL and 40 mg/mL), one of the longest-used MS therapies. This is the third major generic competitor and pushes prices further down ([Practical Neurology, Jan 2026](https://practicalneurology.com/news/generic-glatiramer-acetate-injection-approved-for-multiple-sclerosis/2485224/)).
Why it matters
Glatiramer acetate (originally Copaxone) is a moderate-efficacy injectable with one of the safest profiles in MS — used for over 25 years, no significant immune suppression, safe in pregnancy. Generic competition makes it dramatically cheaper, which matters most for countries where DMT budgets are tight (including Serbia) and for patients who need a low-risk option around pregnancy.
What is on the regulator's desk right now
- Frexalimab (anti-CD40L, Sanofi) — phase 3 FREXALT in RMS and FREVIVA in nrSPMS are running; first phase 3 readouts expected 2026–2027. Mechanism: blocks the CD40L/CD40 co-stimulatory pathway without depleting B cells.
- Remibrutinib (Novartis BTK inhibitor) — phase 3 REMODEL-1 and REMODEL-2 in RMS reported positive top-line results; EU and FDA filings expected in 2026 ([Novartis pipeline](https://www.novartis.com/research-development/novartis-pipeline)).
- Fenebrutinib (Roche BTK inhibitor) — phase 3 FENhance, FENtrepid and FENopta running in both relapsing and primary progressive MS; readouts 2026–2027.
- EBV-targeted T-cell therapy ATA188 (Atara Biotherapeutics) — phase 2 EMBOLD data published in 2024 showed sustained disability improvement in some progressive MS patients; phase 3 program being designed.
- CAR-T cell therapy for refractory MS — early case series (Schett group, Erlangen) showed remission in severe autoimmune disease including MS-like syndromes; first formal MS trials launched in 2025.
What this means for Serbia
None of the three approvals above are on the RFZO Lista C today ([RFZO Lista lekova](https://rfzo.rs/index.php/davalciusluga/lekovi-info/lekovi-lista)), but each will likely arrive in a different way:
- Cenrifki (tolebrutinib): As an EU centrally-authorised drug, it can be registered with ALIMS (Serbian Medicines Agency) once Sanofi files locally — usually 6–18 months after EU approval. RFZO inclusion typically takes another 1–3 years and depends on price negotiations and the size of the nrSPMS population in Serbia (estimated 2,000–3,000 patients based on national MS prevalence; [Pekmezović et al., 2006](https://onlinelibrary.wiley.com/doi/10.1111/j.1600-0404.2006.00701.x)).
- Pediatric Ocrevus: Ocrelizumab is already on RFZO Lista C for adults. The pediatric indication should be added administratively once the EU label is updated by EMA (expected H2 2026).
- Generic glatiramer: Glatiramer acetate is already available in Serbia. New generics typically reduce RFZO's wholesale price within 12 months — which frees budget for newer drugs.
Practical takeaways for patients
- If you have nrSPMS: Talk to your neurologist about whether Cenrifki could become available through an early-access or named-patient program before official RFZO coverage. Bring the [Sanofi press release](https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-23-05-00-00-3315699) and the [HERCULES NEJM paper](https://www.nejm.org/doi/full/10.1056/NEJMoa2407625) to the appointment.
- If your child has MS: Pediatric Ocrevus is now an option in countries where the local label has been updated; in Serbia, expect access within 6–12 months once ALIMS updates the registration. Pediatric MS care should always go through a specialised pediatric neurology centre (in Serbia: Univerzitetska dečja klinika Tiršova, Institut za zdravstvenu zaštitu majke i deteta Srbije „Vukan Čupić").
- If you are on glatiramer: Generics are bioequivalent — switching is safe, but always coordinate with your neurologist to avoid confusion at the pharmacy and to log it correctly for RFZO renewals.
- For everyone: Do not stop or switch your current DMT based on the news. Cenrifki targets a specific population (nrSPMS, no relapses); if you are still having relapses or have active lesions on MRI, ocrelizumab, ofatumumab, natalizumab, cladribine or fumarate remain the standard-of-care options.
How approvals actually happen — quick primer
Many readers ask: "If it is approved in the EU, why can't I get it tomorrow?" Three steps separate EU approval from a prescription at your local clinic:
1. EU central approval by EMA + European Commission — gives Sanofi the right to sell in any EU country.
2. National registration — for Serbia, Sanofi has to file with ALIMS and pay registration fees; legally required even though EMA already approved it.
3. Reimbursement listing (RFZO Lista C) — once registered, the drug enters price negotiations with RFZO; only then is it free at the point of care. Until then, patients sometimes access it via early-access programs or by paying out of pocket (Cenrifki annual cost is expected in the €25,000–35,000 range based on comparable EU BTK inhibitors).
2026 is the year MS treatment finally has a tool aimed at the part of the disease no drug has previously touched — slow, smoldering progression without relapses. Tolebrutinib is not a cure and not perfect (liver monitoring required, FDA still pending), but it opens an entirely new chapter. Combined with pediatric Ocrevus and cheaper generic glatiramer, MS care in 2026 is more personalised, more accessible at both ends of the disease, and more aimed at long-term disability than at any previous moment in the field.
Sources
European Commission. Cenrifki (tolebrutinib) — Centralised authorisation, June 2026. EMA EPAR — Cenrifki: https://www.ema.europa.eu/en/medicines/human/EPAR/cenrifki. Sanofi press release. Cenrifki approved in the EU for nrSPMS, 23 June 2026: https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-23-05-00-00-3315699. Fox RJ et al. Tolebrutinib in non-relapsing secondary progressive MS (HERCULES). NEJM 2024: https://www.nejm.org/doi/full/10.1056/NEJMoa2407625. FDA Complete Response Letter — tolebrutinib NDA 219624, Dec 2025: https://download.open.fda.gov/crl/CRL_NDA219624_20251223.pdf. Sanofi update on US tolebrutinib submission, 24 Dec 2025. Genentech. FDA approves Ocrevus for pediatric RRMS (10+), 8 May 2026: https://www.gene.com/media/statements/ps_050826. Practical Neurology / NeurologyLive — Generic glatiramer acetate FDA approval, Jan 2026. Hauser SL et al. Ocrelizumab vs interferon beta-1a in RRMS (OPERA I/II). NEJM 2017. Pekmezović T et al. Epidemiology of multiple sclerosis in Belgrade, Serbia. Acta Neurol Scand 2006. RFZO — Lista lekova: https://rfzo.rs/index.php/davalciusluga/lekovi-info/lekovi-lista. This article is educational, does not constitute medical advice, and should not be a basis for changing therapy without consulting your neurologist.