The approval follows a positive recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP), and means that MS patients in the European Union may now be infused with this therapy over two hours twice a year, instead of the 3.5 hours every six months previously required for Ocrevus, easing the burden of administration for patients.
“The approval of a shorter, two-hour infusion time for Ocrevus in Europe, dosed twice yearly, will further improve the treatment experience for patients while also increasing capacity in healthcare systems,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, said in a press release.
“With more than 160,000 people treated with Ocrevus globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS,’’ Garraway added.
The immune system plays a critical role in MS onset and progression. In patients, immune cells travel from the blood into the brain, where they wrongly attack the protective myelin sheath that covers neurons and initiate a set of inflammatory reactions that eventually cause these nerve cells to die.
Ocrevus, developed by Genentech, a member of the Roche Group, targets mature immune B-cells that contribute to myelin and nerve cell damage in MS patients. The therapy lowers disease progression/activity and lesion burden in those with primary progressive MS and relapsing forms of the disease (including relapsing-remitting MS and active secondary progressive MS).
Ocrevus is approved in both the U.S. and Europe for these two indications. It is administered as a 600 mg dose every six months — with the first dose being split in two and given two weeks apart — and, as initially approved, infused over a period that typically ran 3.5 hours.
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