Swiss regulatory authorities approved Ocrevus (ocrelizumab) as a treatment for primary progressive and relapsing forms of multiple sclerosis (MS) on Sept. 28, making it the first approval of the drug in a European country.
Since Switzerland is not part of the European Union, the approval will not affect the drug’s regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia.
“The approval of Ocrevus in Switzerland, the first in Europe, is a significant moment for the Swiss MS community, and we are pleased that the regulators have recognized how the clinically meaningful results for Ocrevus may benefit people with active relapsing forms of MS and primary progressive MS,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development, said in a press release.
“Despite available therapies, some people with relapsing forms of MS continue to experience disease activity and disability progression, and people with primary progressive MS, who have never had an approved treatment, experience a faster accumulation of disability,” she said. “Ocrevus, given every six months, has the potential to transform the treatment of both relapsing forms of MS and primary progressive MS.”
Like other countries where Ocrevus has been approved, it’s the first drug OK’d in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS.
“The approval of Ocrevus for both active relapsing forms of MS and primary progressive MS in Switzerland is much welcomed news for people with one of these two forms of MS that can radically alter the lives of those affected and their families,” said Ludwig Kappos, MD, head physician of the Department of Neurology and Outpatient Clinic at the University Hospital of Basel.
“Ocrevus offers people with active relapsing forms of MS a treatment with a favorable benefit/risk profile and is the first medicine demonstrating efficacy and delaying the progression of disability in people with primary progressive MS,” Kappos added.
Ocrevus — an antibody that targets B-cells with the surface factor CD20 — was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease.
The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS.
Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections.
Since its approval, researchers also have concluded that the treatment is less expensive than interferon.
Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups.
Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance.
The European Medicines Agency (EMA) is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.