OPERA

Starting treatment with Ocrevus early can lower almost by half the need for a walking aid in people with relapsing forms of multiple sclerosis (MS) over six years, new analyses of Phase 3 trial data that compared immediate initiation with a two-year delay show. A separate analysis also found…

For multiple sclerosis (MS) patients with considerable disability, Ocrevus (ocrelizumab) appears to lower the risk of continued progression in both relapsing and primary progressive forms of the disease, data from an exploratory and post-hoc analysis of three Phase 3 trials report. These findings were in the study, “…

Treating relapsing multiple sclerosis (MS) patients with Ocrevus (ocrelizumab) is not associated with retinal thinning — unlike treatment with Rebif (interferon beta-1a), according to two Phase 3 trials. The findings also showed a link between retinal thinning and brain volume loss. The study, “…

Treatment for more than six years with Ocrevus (ocrelizumab) is linked to lower levels of blood antibodies among people with primary progressive multiple sclerosis (PPMS) and relapsing MS, but rates of serious infections also remain low, an analysis of data from three Phase 3 trials show. Dropping below a certain…

Treatment with Ocrevus (ocrelizumab) over five years lessened upper limb disability progression in primary progressive multiple sclerosis (PPMS) patients, reduced relapses and brain disease activity in patients with relapsing MS, and helped achieve no evidence of disease progression (NEDA) in a greater proportion of African-descent patients, compared to treatment…

Long-term treatment with Ocrevus (ocrelizumab)  — as well as switching from Rebif (interferon beta-1a) to Ocrevus — leads to a significant and sustained reduction in disease activity in relapsing forms of multiple sclerosis (MS). These previously reported findings are further supported by the latest results drawn from pooled data…

Continuous treatment with Ocrevus (ocrelizumab) or switching from Rebif (interferon beta-1a) to Ocrevus leads to a significant long-term reduction in relapsing multiple sclerosis activity, a two-year extension study shows. Ocrevus’s maker, Genentech, drew the results from an open-label extension of the Phase 3 OPERA trials. Researchers will present the findings at…

Ocrevus (ocrelizumab) was more effective than Rebif (interferon beta-1a) at preventing relapsing multiple sclerosis activity, according to an analysis that covered two Phase 3 clinical trials. The comparison dealt with the therapies’ ability to generate and maintain a condition known as no evidence of disease activity,…

Health Canada has approved Ocrevus for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, Roche Canada announced. 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 1 and OPERA 2 trials showed that Ocrevus significantly reduced disease activity and disability progression of RRMS patients, with annual relapse rates falling by almost half. Moreover, Ocrevus outperformed Rebif, the standard of care in MS, in slowing worsening of disability and significantly reducing lesions seen on 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, in contrast to the U.S. Food and Drug Administration's 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.

Multiple sclerosis patients who benefited from Ocrevus (ocrelizumab) in two Phase 3 clinical trials continued to benefit when they extended their treatment, researchers reported. In fact, their annual relapse rates have fallen even further during the extension study than during the trials. The study, “Preliminary Results of the OPERA I and…

Twenty years ago, the idea that B-cell depletion could treat multiple sclerosis would have been greeted with a hearty laugh by any well-respected neurologist or MS researcher — or perhaps a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may be the most powerful drug yet developed against…

March 28, at the latest, may be a historic date for the multiple sclerosis (MS) community — patients, families, caregivers, researchers, and physicians alike. The U.S. Food and Drug Administration (FDA) will have its say about the marketing approval for Ocrevus (ocrelizumab). The drug will be the first to offer benefit to…

Below is a transcript of the Multiple Sclerosis News Today interview with Dr. Peter Chin — principal medical director at Genentech — about the importance of the pending U.S. Food and Drug Administration (FDA) approval of a Biologics Licensing Application (BLA) for Ocrevus (ocrelizumab). An an indepth article on this interview, looking Ocrevus…

Ocrevus (ocrelizumab), an investigational monoclonal antibody, significantly decreases disease activity in patients with multiple sclerosis (MS), and is associated with a higher proportion of patients reaching no evidence of disease activity (NEDA), according to a new analysis. The study, “NEDA analysis by epoch in patients with relapsing multiple…

A detailed analysis of relapsing and primary progressive multiple sclerosis (MS) patients in the three Phase 3 trials of Ocrevus (ocrelizumab) showed that the treatment did not significantly increase their risk of infections — serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…

Recently published data from three Phase 3 trials of Ocrevus (ocrelizumab) show that the investigational drug does what no other therapy has achieved so far — working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS). Publications in the New England Journal…

The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) for Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval for Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and — for a first…

Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…

Positive new data from Phase 3 clinical trials assessing Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigational therapy. The results are being presented at the 32nd Congress of the…

Genentech, a member of the Roche Group, was founded more than 35 years ago and has been focused on a variety of research fields, including cancer, immunology, neurodegenerative disorders, metabolic diseases, and infectious diseases. Genentech has been committed to discovering and developing new medicines for patients with major diseases of the nervous…

Genentech, a leading biotechnology company and member of the Roche Group, recently announced promising results on a pivotal Phase III clinical trial (ORATORIO) assessing its investigational therapy ocrelizumab as a treatment for patients with primary progressive multiple sclerosis (PPMS). Multiple sclerosis (MS) is a chronic, progressive neurodegenerative disorder that results from…