Roche’s OCREVUS approved for relapsing and primary progressive multiple sclerosis in Australia
Roche announced that OCREVUS (ocrelizumab) has been approved by the Australian Therapeutic Goods Administration (TGA) for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), marking the second approval of OCREVUS for both indications following the FDA decision in the US in March 2017. Marketing applications for OCREVUS are currently under review in over 50 countries across the world, including in Europe, Latin America and the Middle East.
“We are pleased that another regulatory body recognised 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,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Approval in Australia is significant because of the high prevalence of MS in the country, with over 23,000 people in the prime of their lives affected, making it the leading cause of non-traumatic disability in young adults. Moreover, people with PPMS, who often experience faster and more severe disability, have not had any approved treatment until OCREVUS. We continue to work closely with regulatory authorities across the world to bring OCREVUS to people with multiple sclerosis as soon as possible.”
Disability accumulates twice as fast in PPMS as in RMS, meaning that people with PPMS may have to rely on mobility aids or become wheelchair bound, are unable to work, and need carers to look after them sooner. Additionally, a recent article in Multiple Sclerosis Journal noted that the quality of life for a person with MS with severe disability (Expanded Disability Status Scale >7), as measured by EQ-5D mean utility scores, ranks among the worst for chronic conditions.2 Although treatments are available for RMS, the most common form of MS at diagnosis, people with PPMS in Australia have not had an approved disease-modifying treatment until now. OCREVUS is the first and only approved treatment for this type of MS in the US and in Australia.