The European Commission has approved Roche’s Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union.
The commission’s move — nearly 10 months after the U.S. Food and Drug Administration (FDA) approved Ocrevus in March 2017 — makes it the first approved PPMS treatment in Europe.
The Swiss pharmaceutical giant didn’t specify when patients can expect the treatment to become available in individual EU member states, but said it is working with authorities to provide access as quickly as possible.
“For people in Europe living with MS, today’s approval of Ocrevus by the European Commission signifies an important advance in the treatment of their disease,’’ Dr. Sandra Horning, Roche’s chief medical officer and head of Global Product Development, said in a press release. “Ocrevus is the first medicine to be approved for primary progressive MS, a debilitating form in which irreversible disability accumulates rapidly, and it provides a highly efficacious treatment option for people with relapsing forms of MS.”
PPMS accounts for about 96,000 of the 700,000 or so MS cases throughout the EU. Last November, the European Medicines Agency (EMA) recommended the drug’s approval.
In evaluating Ocrevus, the EMA scrutinized data from 2,388 patients in three Phase 3 clinical trials: OPERA 1 and OPERA 2 (NCT01247324 and NCT01412333) in relapsing patients, and ORATORIO (NCT01194570) in primary progressive patients.
Among RRMS patients, Ocrevus robustly lowered relapse rates and the appearance of new brain lesions compared to Rebif (interferon beta-1a). It also triggered NEDA, or no evidence of disease activity, in 64 percent of patients in OPERA 1, and 89 percent of patients in OPERA 2. NEDA is a composite measure requiring no relapses, no new brain lesions seen on brain scans, and no disability progression.
The PPMS trial, which compared Ocrevus to placebo, showed a 25 percent reduced risk of disability progression with Ocrevus treatment. Treated patients also lowered their brain lesion load and slowed their loss of brain tissue. Some also improved their walking ability.
“It is great news that Ocrevus, which has the potential to be a significant game changer in how we think about and treat MS, has been approved in the European Union today,” said neurology professor Gavin Giovannoni of Barts and The London School of Medicine and Dentistry, Queen Mary University of London. “Until Ocrevus, people with primary progressive MS, who often have to rely on a cane or wheelchair, give up work or have carers look after them, have not had an approved treatment to slow the progression of their disease.”
While Ocrevus — a treatment given by infusion — is considered very effective, it also ranks among the safest high-efficacy MS disease-modifying treatments. Even though it depletes immune B-cells, trial data showed that infections were similarly common among Ocrevus-treated and control patients. Infusion reactions and common colds, mostly mild or moderate, were among the most common side effects seen in the studies.
“People with relapsing forms of MS often have to make difficult trade-off choices between safety and higher efficacy,” said Giovannoni. He added that dosing of Ocrevus — once every six months without the need for monitoring — will help MS patients live their lives without continuously thinking about their treatment.