Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis
pharmafile | June 28, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation
Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its Ocrevus (ocrelizumab) to treat multiple sclerosis.
The US Food and Drug Administration (FDA) has also accepted Roche’s Biologics License Application (BLA) for Ocrevus, and has granted the application priority review designation with a targeted action date of December 28, 2016.
Sandra Horning, chief medical officer, said: “Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS. We are pleased by the acceptance of our marketing applications for Ocrevus, which we believe has the potential to help people living with either of these two forms of MS. We will continue to work closely with the EMA and FDA to bring this investigational medicine to people with MS as quickly as possible.”
The marketing applications are based on positive results from three Phase III studies.
Ocrevus is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS.
Multiple sclerosis is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage.
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