Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) intravenous infusion for the treatment of pediatric patients 10 years of age and older with relapsing-remitting multiple sclerosis (RRMS) who weigh at least 55 pounds (25 kg).
Key Clinical Data: Superior Efficacy Compared to Current Standard of Care
In the OPERETTA II study, Ocrevus (ocrelizumab) demonstrated non-inferiority in reducing annualized relapse rate (ARR) compared to fingolimod (the only previously FDA-approved treatment for pediatric RRMS), and showed superiority on the following key endpoints:
Number of new or enlarging T2 lesions: 48% reduction compared to fingolimod.
Number of gadolinium-enhancing T2 lesions: 87% reduction compared to fingolimod.
Safety profile: Consistent with that observed in adult patients.
The safety profile observed in pediatric patients was consistent with that seen in adults. The incidence of serious adverse events and serious infections was low and balanced between the two groups. No patients in the Ocrevus (ocrelizumab) group discontinued treatment due to adverse events, whereas 3 patients in the fingolimod group discontinued for this reason.
Filling the Gap in High-Efficacy Treatment Options for Children
“This approval marks a milestone for children with multiple sclerosis and their families in the United States, helping to fill a long-standing gap in high-efficacy treatment options for patients aged 10 and older,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech. “By bringing a decade of efficacy and safety data to this younger population, Ocrevus (ocrelizumab) has the potential to reduce relapses and may redefine what is possible for their future treatment.”
“I grew up with multiple sclerosis and know firsthand the frustration of being overlooked and the fear of what’s to come,” said Emily Blosberg, founder of Oscar Monkey and a person diagnosed with MS at age 15. “Now, age-appropriate children and adolescents having access to a high-efficacy treatment option like Ocrevus (ocrelizumab) approved by the FDA is a game-changer. It means the next generation of patients doesn’t have to wait for answers—they have the opportunity to take control of their disease early, stopping relapses and brain lesions before they can cause damage.”
About Ocrevus (ocrelizumab)
Ocrevus (ocrelizumab) is a prescription medicine used to treat:
Adults
Relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) and primary progressive multiple sclerosis.
Pediatric Patients (10 years of age and older, weighing at least 55 pounds/25 kg)
Relapsing-remitting multiple sclerosis.
It is not known if Ocrevus (ocrelizumab) is safe and effective in children under 10 years of age or weighing less than 55 pounds (25 kg).
Important Safety Information
1. Who should not receive Ocrevus (ocrelizumab)
Do not receive Ocrevus (ocrelizumab) if you:
Have an active hepatitis B virus (HBV) infection;
Have had a life-threatening allergic reaction to Ocrevus (ocrelizumab) in the past. Tell your healthcare provider if you have ever had an allergic reaction to Ocrevus (ocrelizumab) or any of its ingredients.
2. About Ocrevus (ocrelizumab)
Ocrevus (ocrelizumab) may cause serious side effects, including:
Infusion reactions: Common, can be severe and require hospitalization. You will be monitored during each infusion and for at least 1 hour after each infusion.
Infections: Common. Ocrevus increases the risk of upper respiratory, lower respiratory, skin, and herpes infections. Serious infections can be life-threatening or lead to death. Tell your healthcare provider right away if you have an infection; they should delay treatment until the infection resolves.
Progressive Multifocal Leukoencephalopathy (PML): A rare brain infection that usually leads to death or severe disability, has been reported with Ocrevus use. Symptoms worsen over days to weeks.
Decreased immunoglobulins: Your healthcare provider will monitor this with blood tests.
Cancer risk (including breast cancer): Follow standard breast cancer screening guidelines.
Colitis: Tell your doctor right away if you experience diarrhea, blood in your stool, or abdominal pain.
Liver injury: Tell your doctor right away if you experience yellowing of the skin or whites of the eyes, nausea, vomiting, unusually dark urine, tiredness, loss of appetite, or right upper stomach discomfort.
These are not all the possible side effects. For more information, consult your healthcare professional.
