The US Food and Drug Administration (FDA) has approved a shorter infusion time for ocrelizumab (Ocrevus) for patients with relapsing or primary progressive multiple sclerosis (MS), the company has announced.
Ocrelizumab is administered twice yearly. The FDA decision shortens the infusion time to 2 hours. Previously, infusions required 3.5 hours.
The approval was based on data from the randomized, double-blind ENSEMBLE PLUS study, which showed that frequency and severity of infusion-related reactions with a 2-hour infusion were comparable to those of the conventional 3.5-hour infusion.
The frequency of infusion reactions was 24.6% with the 2-hour infusion and 23.1% with the 3.5-hour infusion.
The majority of infusion-related reactions were mild or moderate, and more than 98% resolved in both groups without complication.
No patient discontinued the study because of an infusion-related reaction, and no new safety signals were detected.
"More than 170,000 people with MS have been treated with Ocrevus ― the only approved B-cell therapy with a twice-yearly dosing schedule ― and it is the most prescribed MS medicine in the US," Levi Garraway, MD, PhD, Roche's chief medical officer, said in a statement.
"We believe people with relapsing and primary progressive MS will find the shorter 2-hour Ocrevus infusion time to be more convenient," he added.
The European Medicines Agency approved the shorter 2-hour infusion time for ocrelizumab last spring.
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Cite this: FDA Approves Shorter Infusion Time for MS Drug Ocrelizumab - Medscape - Dec 15, 2020.