Key takeaways:
- The FDA approved ocrelizumab for treatment of relapsing-remitting MS in children aged 10 years and older.
- Ocrelizumab has previous approvals for treating certain adults with MS.
The FDA has approved IV ocrelizumab for treatment of relapsing-remitting MS in children and adolescents aged 10 years and older and weighing at least 55 pounds, according to Genentech.
Ocrelizumab (Ocrevus, Genentech) has previously been approved to treat adults with primary progressive MS, and relapsing forms, including active secondary progressive disease, clinically isolated syndrome and relapsing-remitting disease.
The FDA has approved IV ocrelizumab for treatment of relapsing-remitting MS in children and adolescents aged 10 years and older.
“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a press release. “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.”
In the OPERETTA II trial, ocrelizumab demonstrated improved rates of reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions compared with fingolimod (Gilenya, Novartis), and noninferiority in annualized relapse rate.
Serious adverse events associated with ocrelizumab include infusion reactions, infection, decreased immunoglobulins, progressive multifocal leukoencephalopathy, colitis and liver damage, and it may increase risk for cancer.
Sources/Disclosures
Source:
Press release
Reference:
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