The US FDA approval is based on data from the ENSEMBLE PLUS study, in which two-hour Ocrevus infusion time showed consistent safety results
Roche Diagnostics Ltd administration and R&D buildings, Rotkreuz. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has received the US Food and Drug Administration (FDA) approval for Ocrevus (ocrelizumab) with a shorter two-hour infusion time to treat a type of multiple sclerosis (MS).
FDA indicated the Ocrevus twice-yearly dose for relapsing or primary progressive MS in patients who have not experienced any serious infusion reactions (IRs) previously.
In April this year, the company’s supplemental biologics license application (sBLA) has been accepted by the US FDA, for a two-hour Ocrevus infusion time for the treatment of MS.
The European Medicines Agency (EMA) has validated the same indication for Ocrevus in May 2020, based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell, believed to cause myelin and axonal damage, which may cause disability in people with MS.
The drug is currently approved in 94 countries across North America, South America, the Middle East, Europe, and Australia.
Roche chief medical officer and global product development head Levi Garraway said: “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 U.S.
“We constantly strive to improve the experience that patients and their physicians have with our medicines, and we believe people with relapsing and primary progressive MS will find the shorter two-hour OCREVUS infusion time to be more convenient.”
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.
The US FDA approved the company’s sBLA for two-hour Ocrevus infusion time, based on the data from ENSEMBLE PLUS, a randomised, double-blind clinical study.
ENSEMBLE PLUS study demonstrated a similar frequency and severity of IRs for both two-hour Ocrevus infusion time, and the previously approved 3.5-hour time, in relapsing-remitting MS (RRMS) patients.
In the clinical study, the first dose was administered as per the approved dosing schedule and the second or later doses were administered over a shorter, two-hour time.
The proportion of patients with IRs after the first randomised 600mg infusion was the primary endpoint of this study.
The frequency of IRs was comparable between those who received the two-hour infusion and those who received the 3.5-hour infusion, said the company.