CHMP Recommends EU Approval for Ocrelizumab in Pediatric Relapsing MS

In a new company update, Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Ocrevus (ocrelizumab) intravenous infusion for pediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS). The recommendation follows findings from the phase 3 OPERETTA 2 study, which evaluated ocrelizumab against fingolimod in pediatric patients with relapsing-remitting MS.¹

The European Commission (EC) is expected to issue a final decision following the CHMP’s positive opinion. Earlier, in May, the FDA approved ocrelizumab for pediatric patients with relapsing MS in the United States.

“Children and teens living with multiple sclerosis experience more frequent and severe relapses than adults, yet their treatment options have lagged behind,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in a statement.¹ “The positive CHMP opinion brings us closer to bridging a longstanding gap in Europe, offering young people with MS a high-efficacy therapy backed by a decade of adult experience.”

OPERETTA 2 Data

The CHMP recommendation was based on findings from OPERETTA 2, a phase 3 study comparing intravenous ocrelizumab with fingolimod in pediatric patients with relapsing-remitting MS. In the trial, 187 pediatric patients were assigned to ocrelizumab 600 mg intravenously every 24 weeks or fingolimod 0.5 mg orally once daily. Overall, ocrelizumab met the primary end point of noninferiority, reducing annualized relapse rate by 48% relative to fingolimod (rate ratio, 0.52; 95% CI, 0.19-1.33).²

Ocrelizumab also demonstrated greater reductions in MRI disease activity, with 48% fewer new or enlarging T2 lesions (rate ratio, 0.52; 95% CI, 0.36-0.76; P = .001) and 87% fewer gadolinium-enhancing T1 lesions at 12 weeks (rate ratio, 0.13; 95% CI, 0.03-0.41; P = .001). Participants had a median age of 15 years and baseline EDSS score of 1.5, with a mean of 57 T2 lesions and 47.1% having at least 1 gadolinium-enhancing lesion at baseline.

Safety Findings in Pediatric Patients

Roche reported that the safety profile of ocrelizumab in children and adolescents was consistent with the established safety profile observed in adults. No patients in OPERETTA 2 discontinued treatment because of adverse events (AEs), according to the announcement.

Mechanistically, ocrelizumab is a humanized monoclonal antibody that targets CD20-positive B cells, which contribute to immune-mediated processes involved in myelin and axonal damage in MS. The therapy is administered by intravenous infusion every 6 months following an initial dosing regimen consisting of two 300-mg infusions administered 2 weeks apart. Subsequent doses are administered as single 600-mg infusions.

If approved by the EC, the recommendation would support the expansion of ocrelizumab as a treatment option for pediatric patients with relapsing MS in the European Union.

Addressing Treatment Needs in Pediatric MS

Pediatric-onset MS is associated with inflammatory disease activity, including relapses and the accumulation of MRI lesions. In its announcement, Roche cited an estimate of at least 40,000 children and adolescents living with MS worldwide, with approximately one-third residing in Europe.¹

Brenda Banwell, MD, chair of pediatrics at Johns Hopkins Medicine, pediatrician-in-chief and co-director of the Johns Hopkins Children’s Center, noted that pediatric MS can involve unpredictable relapses, hospitalizations, acute treatments, and disruptions to school and social activities.

“Extending Ocrevus, a proven treatment for adults, to younger patients is an important step forward to suppress disease activity early on, with the goal of preserving their physical and cognitive health,” Banwell said in a statement.1

The CHMP recommendation represents a regulatory step toward expanding the use of ocrelizumab in pediatric MS. The EC’s final decision is required before the recommendation becomes an authorization applicable across the European Union.

REFERENCES
1. CHMP recommends EU approval of Roche’s Ocrevus for children and adolescents with relapsing multiple sclerosis. Roche. News Release. September 18, 2026. Accessed September 21, 2026. https://www.globenewswire.com/news-release/2026/09/18/3364612/0/en/chmp-recommends-eu-approval-of-roche-s-ocrevus-for-children-and-adolescents-with-relapsing-multiple-sclerosis.html_gl=1*1u33qxf*_up*MQ..*_ga*NDAxNTQ4NC4xNzg5OTIyODI0*_ga_B6167QB2TF*czE3ODk5MjI4MjMkbzEkZzAkdDE3ODk5MjI4MjMkajYwJGwwJGgxNTg1MzIyNDMz*_ga_ERWPGTJ5X8*czE3ODk5MjI4MjMkbzEkZzAkdDE3ODk5MjI4MjMkajYwJGwwJGg