The medication is the first ever treatment for people with a certain form of the Mississippi – and for another 85,000 Mississippi patients offers a far more effective alternative to existing drugs.
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The Swiss pharmaceutical giant Roche announced the headline results for its drug, ocrelizumab, but has not published the detailed outcome of its trials. “For decades, trial after trial has failed to show the benefit of any medicine for people with primary progressive Mississippi. Now, for the first time, we have a positive Phase III study result for people with this debilitating form of the disease”. While acute relapses typically happen perhaps once a year in the relapsing form of the disease, magnetic resonance imaging studies have shown that bursts of inflammatory attacks on myelin are much more frequent, he said.
There’s no approved treatment for primary-progressive Mississippi, which involves a steady worsening of brain function and affects about 10 percent of all patients.
Given that the drug is created to selectively target CD20-positive B cells, Roche said the fact that efficacy was shown across both forms of Mississippi “validates the hypothesis that B cells are central to the underlying biology of the disease”. The results are to be presented Friday in Barcelona at a meeting of European medical experts on multiple sclerosis.
“Finding effective treatments for multiple sclerosis is our number-one priority at the MS Society and this is a big moment”.
Roche plans to seek regulatory approval for ocrelizumab in early 2016, implying it could reach the market around a year later.
Multiple sclerosis is a chronic disease that affects an estimated 2.3 million people around the world, according to the company.
The disease either become progressively worse with age – or strikes in brutal, periodic relapses – with many people left relying on wheelchairs.
The medicine is Roche’s first in multiple sclerosis.
Mississippi patients and their advocates welcomed Thursday’s announcement, especially for those with the progressive form who now are limited to drugs that reduce symptoms but don’t address the mechanisms of the disease.
Two trials of MS relapsing were performed in Mississippi.
“It’s the most promising I’ve felt in a very long time”, she said of the potential of the new drug.
‘People with primary progressive Mississippi and clinicians alike have been eagerly waiting for an effective treatment to slow the path of relentless deterioration’.
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Bruce Bebo, executive vice president of research for the National Multiple Sclerosis Society, said he looks forward to seeing the detailed safety and effectiveness results from the trials.
