The US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) for children aged 10 years and older with relapsing-remitting multiple sclerosis (RRMS), marking only the second therapy formally approved for paediatric MS in the United States.
The decision applies to children and adolescents weighing at least 25kg and is being described by Genentech as a significant step forward in access to high-efficacy treatment options for younger patients living with multiple sclerosis (MS). Until now, Gilenya (fingolimod) had been the only FDA-approved disease-modifying therapy specifically indicated for paediatric MS.
The FDA approval was supported by results from the Phase 3 OPERETTA 2 clinical trial, which enrolled 187 children and adolescents with MS. Participants received either Ocrevus infusions or the oral therapy Gilenya over a two-year period.
According to the study findings, Ocrevus reduced the risk of relapse by 48% compared with Gilenya. The treatment also significantly reduced the number of new or enlarging brain lesions and lowered the number of active inflammatory lesions by 87%.
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Researchers reported that the safety profile in paediatric patients was consistent with previous findings in adults. No participants receiving Ocrevus discontinued treatment because of side effects during the trial.
Patient advocates welcomed the approval, highlighting the importance of earlier access to effective therapies for younger people with MS. Emily Blosberg, founder of the non-profit organisation Mr. Oscar Monkey, said the approval could help children gain earlier disease control and potentially reduce long-term neurological damage.
This news item has been summarised using AI and checked by humans before publication.
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