Monday, 26 June 2017

FDA Approves 1st Drug for Treating Aggressive Multiple Sclerosis

20 April 2017 | News | By BioSpectrum Bureau

FDA Approves 1st Drug for Treating Aggressive Multiple Sclerosis

Genentech, a member of the Roche Group recently announced U.S. Food and Drug Administration (FDA) has approved OCREVUSTM (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.

The decision to approve the drug for primary progressive MS was based on a Roche-sponsored clinical trial involving 732 patients, in which they found that patients on the drug were about 25% less likely to have their condition worsen when compared to the dummy infusions.

Even though 14 drugs have been approved till now for the most common type of MS, there has been no progress on drugs against primary progressive MS, said Lublin, a consultant to Genentech who was on the committee overseeing the study.

The new drug approved, Ocrelizumab, was based on the research done by Dr. Stephen Hauser, who is currently the Director of the Weill Institute for Neurosciences at the University of California, San Francisco. 40 years ago, when a young woman stepped into his office with this debilitating condition, Dr Hauser, a young doctor back then, was devastated. The disease seemed impossible to treat back then and that's when he decided to pursue research on MS.

When most of the drugs in the market for MS targetted the T cells in the body, which was deemed as the main culprit, Dr Hauser's research proved that B cells played a critical role in the disease and blocked these immune cells.
On hearing about the approval, Dr Hauser said, "It's personally incredibly rewarding. This is a big deal for people with MS."


Dr. Billy Dunn, director of the FDA's Division of Neurology Products in a statement. "This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS."



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