FDA Approves Ocrevus for Relapsing-Remitting Multiple Sclerosis In Pediatric Patients 10 Years of Age And Older

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South San Francisco, CA - May 8th, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus (ocrelizumab) intravenous (IV) infusion for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more. In the OPERETTA II study, Ocrevus demonstrated noninferiority to fingolimod (previously the only FDA-approved treatment for RRMS in pediatrics) in reducing the annualized relapse rate (ARR) and superiority in reducing new or enlarging T2 lesions (48% reduction vs fingolimod) and gadolinium-enhancing T2 lesions (87% reduction vs fingolimod). The safety profile in pediatric patients was consistent with that observed in adult patients. Serious adverse events and serious infections were infrequently observed and well balanced; no adverse events led to treatment withdrawal in the Ocrevus group, and three patients withdrew in the fingolimod group.

"This approval represents a landmark for children living with MS in the U.S. and their families, which can help close the longstanding gap in high-efficacy treatment options for children aged 10 and older," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "By bringing a decade of efficacy and safety data to this younger population, Ocrevus may reduce relapses and potentially redefine what’s possible for their future."

“Growing up with MS, I know the frustration of being dismissed and the fear of what comes next. Having an FDA-approved, high-efficacy treatment option like Ocrevus available for age-appropriate children and adolescents is a game changer,” said Emily Blosberg, founder of Mr. Oscar Monkey, diagnosed with MS at 15 years old. “It means the next generation of patients won't have to wait for answers—they have an opportunity to take control of their disease early and potentially stop relapses and brain lesions before they have a chance to take a toll.”

It is estimated that approximately 5,000-10,000 children and adolescents have pediatric onset of MS in the United States [1].

What is Ocrevus?

Ocrevus is a prescription medicine used to treat:

  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Primary progressive MS, in adults.
  • Relapsing-remitting MS, in children 10 years of age and older who weighs 55 pounds (25 kg) or more.

    • It is not known if Ocrevus is safe and effective in children younger than 10 years of age or who weigh less than 55 pounds (25 kg).

    Who should not receive Ocrevus?

    Do not receive Ocrevus if you:

  • have an active hepatitis B virus (HBV) infection.
  • have had a life-threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.

    • What is the most important information I should know about Ocrevus?

    Ocrevus can cause serious side effects, including:

  • Infusion reactions: Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction.
  • Infection: Infections are a common side effect. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus, which can be life-threatening or cause death. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with Ocrevus. Symptoms of PML get worse over days to weeks.
  • Decreased immunoglobulins: Ocrevus may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

    • What are the possible side effects of Ocrevus?

    Ocrevus may cause serious side effects, including:

  • Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
  • Inflammation of the colon, or colitis: Tell your healthcare provider right away if you have any signs of colitis such as diarrhea, blood in stool, and stomach pain.
  • Liver damage. Ocrevus may cause liver damage. Tell your healthcare provider right away if you have any symptoms of liver damage, such as yellowing of the skin and eyes (jaundice), nausea, vomiting, unusual darkening of the urine, feeling tired or weak, loss of appetite, and discomfort in the upper right area of your stomach (abdomen).

    • These are not all the possible side effects of Ocrevus.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.

    For more information, go to https://www.Ocrevus.com or call 1-844-627-3887.

    About multiple sclerosis

    Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

    Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS. Despite the availability of high efficacy therapies, 30% of patients remain on low-efficacy oral therapy today. Slowing or stopping progression while simultaneously stopping relapses remains a high unmet need in MS.

    About Genentech

    Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

    References

    1 Hoff Communications. (2018, February 22). Who Gets MS? | MSAA. MSAA. https://mymsaa.org/publications/about-ms/who/.

    About Genentech

    Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

    Source: Genentech

    Source: HealthDay

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    Posted : 2026-05-11 09:45

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