Health Canada Approves Ocrevus to Treat Early Stage PPMS Patients with Active Disease

Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), following Health Canada‘s decision to approve its use with restrictions.

Roche/Genentech’s Ocrevus can be prescribed to adults with early-stage PPMS and characteristic signs of inflammatory activity. In Canada as elsewhere, it is the first approved disease-modifying treatment for these patients.

Early stage is defined by disease duration since diagnosis and by disability level, as determined by physical evaluation and the expanded disability status scale (EDSS). Inflammatory status is verified by imaging evaluation of the brain.

Health Canada’s decision came under its Notice of Compliance with Conditions policy that facilitates access to new medicines with demonstrated potential to treat diseases that lack therapeutic options.

“This is exciting news for the MS community,” Karen Lee, vice president of research at the Multiple Sclerosis Society of Canada, said in a press release. “Over the years we have seen many new treatments come to market that manage relapsing-remitting MS (RRMS), but there have been no disease modifying therapies for people living with progressive MS.”

“The approval of Ocrevus is a much-needed treatment for the PPMS community because, for some people living with PPMS, Ocrevus may help control, and even slow disease progression,” Lee added. “Hopefully, this is the beginning of many more treatment options for people living with PPMS.”

The ruling follows others by regulatory agencies elsewhere, such as the U.S. Food and Drug Administration, the European Commission, and the Australian Therapeutic Goods Administration,

Ocrevus’ approval as a PPMS treatment was supported by results of the ORATORIO trial (NCT01194570). The study included 732 participants with PPMS who were randomized to receive Ocrevus or placebo every six months as an infusion.

Trial results showed that Ocrevus-treated patients had a 25 percent lower risk of disability progression sustained for at least 24 weeks compared to those on placebo.The treatment also lessened the volume of brain lesions seen, slowed the loss of brain tissue, and improved walking speeds in the Ocrevus group compared to the placebo group.

The most common treatment-related side effects reported during the trial were infusion-related reactions (40 percent), upper respiratory tract infections (12 percent), and the flu (12 percent).

“The management of progressive MS has long been very frustrating for both patients and clinicians because we have been limited to symptom management,” said Daniel Selchen, a neurologist at St. Michael’s Hospital in Toronto. “The approval of Ocrevus for patients with PPMS affords the opportunity to, for the first time, offer a disease modifying therapy (DMT) to patients with progressive disease.”

“This will benefit some patients both clinically, by delaying disease progression, and psychologically, by offering hope,” Selchen added. “It will be important for clinicians to help manage patient expectations, as not all patients who receive treatment with Ocrevus will benefit and many PPMS patients will not be appropriate candidates for this therapy.”

It is estimated that about 100,000 Canadians live with MS, which is one of the highest prevalence rates in the world. About one in 10 of MS Canadian patients have PPMS.

Mike Schofield, an MS patient and trial participant, said: “Being diagnosed with PPMS and learning that there were no treatment options … left me feeling hopeless … So when my doctor spoke to me about participating in a clinical trial for an experimental medicine, I felt like I had nothing to lose. I’m living proof that research pays off and I’m proud to have been part of the process that has made it possible for other patients to now access Ocrevus.”