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Sunday, February 21, 2016

New drug for severe form of MS generates glimmer of hope — and tempered expectations



DR. W. CRUM/TIM BEDDOW/ SCIENCE SOURCE-- MRI brain scan from a patient with multiple sclerosis.




By DAVID NATHER @DavidNather

FEBRUARY 19, 2016

There is finally some progress in the hunt for a treatment for the most difficult form of multiple sclerosis — the form that has stubbornly resisted every attempt to find a therapy.



The catch, experts say, is that people with this form of the disease should keep their expectations low, because even the new drug that’s now in the last stages of development doesn’t appear to have a big clinical impact.



The reason that the new drug is generating so much interest, though, is that it’s the first time a therapy for primary progressive MS has had any impact at all.



And it’s the first MS drug to ever receive a “breakthrough” designation from the Food and Drug Administration, which puts the experimental medicine on a fast track to get through the review process as quickly as possible. The agency granted the designation earlier this week.



Read more: Father, daughter fight different forms of MS



Primary progressive MS is a relatively rare form of the neurological disease in which a person doesn’t have severe attacks, the way people do with the more common, relapsing-remitting kind. Instead, they suffer a slow, steady physical deterioration with no hope of recovery.



The FDA has approved 13 drugs for treating relapsing-remitting MS, but none have been shown to work for people with primary progressive disease. The new “breakthrough” drug, called ocrelizumab, is one of six that are in various stages of development for this recalcitrant form, one that affects 10 to 15 percent of the estimated 400,000 Americans living with MS.



On Friday, the company behind ocrelizumab, the Roche subsidiary Genentech, will release new Phase 3 trial data at a conference of the Americas Committee for Treatment and Research in Multiple Sclerosis, which is being held in New Orleans.


Genentech has already published a first round of the results, which showed some impact on a wide range of measures for people with primary progressive MS. The new data will include more detail on how ocrelizumab affected subgroups of patients, as well as new information on how it worked in people with relapsing-remitting MS, to show whether it can also work on the more common variety of the disease.


Continuation of article found here



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