Roche chalks up Swiss approval for multiple sclerosis drug Ocrevus
pharmafile | September 28, 2017 | News story | Sales and Marketing | Ocrevus, Roche, multiple sclerosis, pharma, pharmaceutical
Roche has announced that its drug Ocrevus (ocrelizumab) has received marketing approval in Switzerland for the treatment of active relapsing forms of multiple sclerosis (RMS) as well as primary progressive forms of the disease (PPMS). The authorisation from the Swiss regulator Swissmedic marks the first for the drug in Europe after it received approval in North and South America, the Middle East, Australia and Ukraine, indicating that a full European approval may be incoming.
Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, which are thought to nerve cell damage which can lead to disability in MS patients. Within MS, RMS is the most common form of the disease and is characterised by bouts of symptoms followed by periods of complete or incomplete recovery. By contrast, PPMS is much more debilitating, causing disability at double the rate of RMS, often compromising mobility and independence much sooner. Overall, the disease area affects around 15,000 people in Switzerland and 2.3 million worldwide.
The approval decision was based on data which demonstrated superior efficacy from Ocrevus in treating MS based on three major markers of disease activity compared to MSD and Pfizer’s Rebif (interferon beta-1a).
“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 recognised how the clinically meaningful results for Ocrevus may benefit people with active relapsing forms of MS and primary progressive MS,” said Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “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. Ocrevus, given every six months, has the potential to transform the treatment of both relapsing forms of MS and primary progressive MS.”
Professor Ludwig Kappos, Head Physician of the Department of Neurology and Outpatient Clinic at the University Hospital of Basel, also remarked: “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. Ocrevus offers people with active relapsing forms of MS a treatment with a favourable benefit/risk profile and is the first medicine demonstrating efficacy and delaying the progression of disability in people with primary progressive MS.”
Matt Fellows
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