The Australian Therapeutic Goods Administration (TGA) has granted approval for Roche’s Ocrevus (ocrelizumab) for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Multiple sclerosis (MS) is a chronic disease that occurs when the immune system of a human body abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, resulting in inflammation and consequent damage.
This is the second approval of Ocrevus for both indications after the treatment received FDA approval in the US in March.
Ocrevus is a humanised monoclonal antibody that has been designed to target CD20-positive B cells, a specific type of immune cell that is considered to be the primary contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.
Roche chief medical officer and global product development head Dr Sandra Horning said: “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.”
Other treatments are available for RMS, which is the most common form of MS at diagnosis.
However, patients with PPMS, who often experience faster and more severe disability, did not have any approved treatment option in the US and in Australia until the launch of Ocrevus.
The efficacy and safety of Ocrevus in relapsing forms of MS has been evaluated using the results from the Phase III randomised, double-blind, double-dummy, global multi-centre OPERA I and OPERA II trials.
The efficacy and safety of the Roche treatment in primary progressive MS is evaluated through the Phase III, randomised, double-blind, global multi-centre study, ORATORIO.
Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101 / Wikipedia.