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Emerging treatmentsPhase 3 study in peopleEU authorised

Ocrevus for children aged 10 and older with active relapsing MS

EU-authorised indication: Patients aged 10 years and older with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features (intravenous Ocrevus)

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Organisation
Roche Registration GmbH
Regulator
European Medicines Agency · European Union

Ocrevus (paediatric EU indication) · Ocrelizumab reduces CD20-positive B cells. The paediatric programme studied intravenous treatment in children and adolescents with active relapsing multiple sclerosis (MS), including Phase 3 OPERETTA 2 versus fingolimod.

What is being studied

Ocrelizumab reduces CD20-positive B cells. The paediatric programme studied intravenous treatment in children and adolescents with active relapsing multiple sclerosis (MS), including Phase 3 OPERETTA 2 versus fingolimod.

Research stage

Phase 3 study in people

EU-authorised indication; the supporting study continues without new participants.

What we know so far

The European Commission extended the indication on 15 October 2026. The regulatory decision is supported by paediatric human evidence, but is not a new trial result. OPERETTA 2 is active, not recruiting; its posted results are a separate fact. The EMA safety communication of 8 October concerns drug-induced liver injury of unknown frequency and recommends liver-function monitoring.

What this means for patients today

The indication applies to eligible patients aged 10 or older under specialist care. It does not establish Greek access or reimbursement, individual eligibility, superiority, or myelin repair.

Treatment or approach
Intravenous ocrelizumab in active relapsing MS from age 10
How it is intended to work
Anti-CD20 B-cell depletion by ocrelizumab
Where the study is running
European Union; Greek access unverified
Source: European Medicines Agency — official EMA medicine record ↗Source: ClinicalTrials.gov — OPERETTA 2 NCT05123703, active without recruitment, posted results ↗ Source: EMA — separate 8 October 2026 drug-induced liver injury safety communication ↗ Source: EMA — earlier CHMP opinion, 17 September 2026 ↗
Published by MyelinWatch
Last substantive MyelinWatch update

Programme updates — newest research developments first

  1. European Commission indication extension on 15 October 2026; OPERETTA 2 Phase 3 evidence is separateResearch event/source date:

    EU authorises intravenous Ocrevus for active relapsing MS from age 10

    On 15 October 2026 the European Commission extended the EU indication for intravenous ocrelizumab (Ocrevus) to patients aged 10 and older with active relapsing multiple sclerosis (MS), defined by clinical or imaging features. EMA updated its product information on 16 October. The September CHMP opinion was an earlier step. Phase 3 OPERETTA 2 evidence, its registry status and its posted results are separate from this regulatory event.

    Source: European Medicines Agency — official EMA medicine record ↗Source: ClinicalTrials.gov — OPERETTA 2 NCT05123703, active without recruitment, posted results ↗ Source: EMA — separate 8 October 2026 drug-induced liver injury safety communication ↗ Source: EMA — earlier CHMP opinion, 17 September 2026 ↗