Multiple sclerosis is a chronic disease that occurs when the immune system abnormally attacks the parts of nerve cells in the brain, spinal cord and optic nerves
Genentech seeks FDA and EMA validation for Ocrevus infusion time. (Credit: F. Hoffmann-La Roche Ltd.)
The US Food and Drug Administration (FDA) has accepted Genentech, a subsidiary of Roche’s supplemental biologics license application (sBLA) for a two-hour ocrelizumab (Ocrevus) infusion time to treat a type of multiple sclerosis (MS).
In addition, the company has secured the European Medicines Agency (EMA) validation for a two-hour Ocrevus infusion time for relapsing or primary progressive MS.
MS is a chronic disease that occurs when the immune system abnormally attacks the parts of nerve cells in the brain, spinal cord and optic nerves, causing inflammation and consequent damage.
Roche chief medical officer and global product development head Levi Garraway said: “With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90 per cent of patients continuing with treatment through one year.
“We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in healthcare systems.”
Ocrevus is a humanised monoclonal antibody designed to prevent the damage of nerve cells
Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to damage nerve cells. It is the only therapy approved for both RMS and PPMS and is administered by intravenous infusion every six months.
The regulatory applications for Ocrevus are supported by the data from randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRR) for two-hour Ocrevus infusion time.
Ocrevus has been previously approved for 3.5 hour time in patients with relapsing-remitting MS (RRMS).
The first dose includes two 300 mg intravenous infusions administered in two weeks and the second will be 600 mg IV infusion, administered over a shorter, two-hour time.
The primary endpoint of this study was the proportion of patients with IRRs after first randomised 600mg infusion, with frequency or severity assessed during and 24 hours after infusion.