Australian Authorities Approve Ocrevus Following U.S. Endorsement of Breakthrough MS Therapy

Australia has become the first country to approve Genentech’s Ocrevus (ocrelizumab) for relapsing and primary progressive multiple sclerosis (MS) treatment since the therapy’s initial approval by the U.S. Food and Drug Administration in March 2017.

The Australian Therapeutic Goods Administration gave Ocrevus the green light on July 17, filling an unmet need for Australia’s estimated 23,000 MS patients.

“We are pleased that another regulatory body recognized for its rigorous review process has approved Ocrevus with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,” Dr. Sandra Horning, Roche’s chief medical officer and head of global product cevelopment, said in a press release. “Approval in Australia is significant because of the high prevalence of MS in the country, making it the leading cause of non-traumatic disability in young adults.”

The drug’s developer, Genentech, and Genentech’s parent company Roche have submitted applications to get Ocrevus approved in more than 50 countries in Europe, Latin America and the Middle East.

Like their American counterparts, Australian patients with primary progressive multiple sclerosis (PPMS) had — before the approval of Ocrevus — no approved treatment for their condition. That approval was based on three Phase 3 trials — OPERA I and OPERA II (NCT01247324 and NCT01412333) in relapsing-remitting (RRMS) patients, and a third one, ORATORIO (NCT01194570), to explore Ocrevus’ potential benefits in PPMS patients.

The trials showed that, among relapsing patients, relapse rates were nearly halved compared to those treated with Rebif (interferon beta-1a). Many of these patients also reached a level of no disease activity — measures that Genentech has continued to explore after the drug’s U.S. approval.

For instance, data presented at the 3rd Congress of the European Academy of Neurology held June 24-27 in Amsterdam showed that 82 percent of Ocrevus-treated patients reached what researchers referred to as “No Evidence of Progression or Active Disease” or NEPAD.

NEPAD encompasses no relapses; no confirmed disability progression measured by the Expanded Disability Status Scale (EDSS); no progression equal to or above 20 percent on the timed 25-foot walk (which measures mobility and leg function), and the nine-hole peg test (a measure of finger dexterity); and no brain disease activity measured with the help of magnetic resonance imaging (MRI).

PPMS patients in the ORATORIO trial also were seen to benefit, with a 25 percent lower risk of disease progression over 24 weeks, and later analyses showing that 29.9 percent of the patients reaching NEPAD.

In addition, data also showed that PPMS patients, who deteriorate more rapidly, benefit from Ocrevus treatment.

“People with PPMS [primary progressive multiple sclerosis], who often experience faster and more severe disability, have not had any approved treatment until Ocrevus,” Horning said. “We continue to work closely with regulatory authorities across the world to bring Ocrevus to people with multiple sclerosis as soon as possible.”

Ocrevus is an antibody that blocks the CD20 molecule on certain immune B-cells. Researchers believe these cells directly damage myelin — the protective coat that insulates nerve cells in the brain and spinal cord. Evidence also indicates that B-cells can directly damage neurons themselves.

The drug continues to be evaluated in a range of clinical trials, including one that specifically focuses on how the drug’s B-cell depleting actions play out to harness MS disease processes.