Posted by Michael Wonder on 20 Apr 2020
FDA and EMA accept applications for Genentech’s Ocrevus (ocrelizumab) shorter two hour infusion time
19 April 2020 - Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approved.
Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and the EMA has validated the application for a two hour Ocrevus (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis.
The regulatory applications are based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions for a two hour Ocrevus infusion time vs. the currently approved 3.5 hour time in patients with relapsing-remitting multiple sclerosis.
