17 July 2017 - Second approval after the US for Ocrevus as the first and only approved treatment for people with primary progressive multiple sclerosis, a highly disabling form of multiple sclerosis.

Roche announced today that Ocrevus (ocrelizumab) has been approved by the Australian Therapeutic Goods Administration (TGA) for the treatment of relapsing forms of multiple sclerosis and primary progressive multiple sclerosis, 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.”

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