Roche’s Ocrevus has been approved for use in Europe to treat adults with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).
Ocrevus (ocrelizumab) is first-in-class, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal (nerve cell) damage, which can lead to disability in people with MS.
The drug’s approval in Europe marks the first time a medicine has been licensed for use in patients with PPMS, the most debilitating form of the disease, and also widens treatment options for those with RMS, having shown superiority in trials on markers of disease activity and disability progression compared with subcutaneous interferon beta-1a, the firm noted.
According to the data, Ocrevus significantly cut the annualised relapse rate by 46.4 percent at 96 weeks compared with interferon beta-1a treatment in patients with RMS.
For patients with PPMS, treatment with Ocrevus led to a 24 percent reduction in the risk of 12-week confirmed disability progression compared with placebo.
“Ocrelizumab promises to be a valuable new treatment for both relapsing and primary progressive MS” said Jo Sopala, director of development at the MS Trust. “We hope that the availability of this new treatment will lead to a renewed focus on the needs of all people with progressive MS and their access to services.”
Dr Marius Scholtz, country medical lead of Neuroscience at Roche UK, said Roche will now “work closely with the relevant UK bodies to ensure eligible patients are able to access ocrelizumab as quickly as possible.”
MS affects around 100,000 people in the UK.
Ocrevus was approved in the US In March last year.