The approval followed the positive results from the Phase 3 OPERA studies, which evaluated the safety and efficacy of Ocrevus in 825 patients with RRMS. The OPERA I (NCT01247324) and OPERA II (NCT01412333) trials showed that Ocrevus significantly reduced disease activity and disability progression of RRMS patients, with annual relapse rates falling by almost half (46% and 47% in OPERA I and II, respectively).
Moreover, Ocrevus outperformed Rebif (interferon beta-1a), the standard of care in MS, in slowing worsening of disability and significantly reducing lesions seen on magnetic resonance imaging (MRI) scans over a two-year treatment period.
“Ocrevus is a major addition to the treatment options available for MS. The RRMS Ocrevus clinical trial data show a significant reduction in relapses and disease progression, as well as a good safety profile,” Daniel Selchen, a neurologist and head of the Division of Neurology at St. Michael’s Hospital in Toronto, said in a press release. “For appropriate patients, Ocrevus will be of great value in reducing the burden of MS.”
The treatment’s approval, however, did not extend to — or mention — people with primary progressive MS (PPMS), in contrast to the U.S. Food and Drug Administration’s (FDA) action in March, which approved Ocrevus for both MS forms. Health Canada did not give address PPMS in its announcement.
Estimates are that 100,000 Canadians are currently living with MS, and most have the relapsing form. A number welcomed Ocrevus’ arrival for what it offers in their fight against this disease.
“Before Ocrevus, I had symptoms everyday, and there was always the constant hassle of worrying about how I was going to transport the MS medications whenever I traveled,” Ian Gardiner, an MS patient, said in the release. “Since starting the treatment, I feel so much better. I feel that it is keeping my MS in check and my MS symptoms at bay while giving me back control over my life. Due to the dosing regimen, I now have more freedom to travel without the worry of transporting my MS medication.”
Ocrevus is initially administered as two infusions (300 mg each) two weeks apart; all remaining infusions are administered as a single 600 mg infusion at six-month intervals.
“The approval of Ocrevus is good news for people living with MS, as they now have one more treatment option to help manage this unpredictable disease,” said Karen Lee, vice president of research at the Multiple Sclerosis Society of Canada.
“This approval reinforces the need for ongoing research into viable MS treatments. Through continued investment in research, we can accelerate the development of innovative treatments that go through rigorous testing and can help change the prognosis for many people living with MS,” Lee added.
Ocrevus selectively targets B-cells, vital immune system cells that in MS attack the myelin sheath that insulates nerve cells, leading to nerve damage and promoting disability. Ocrevus binds to a protein at the surface of overreactive B-cells, called CD-20, to prevent or limit these attacks.