New multiple sclerosis drug can ‘cut relapses by almost 50%’
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.
In two studies, which included a total of 1,656 patients with relapsing multiple sclerosis, the most common form of the condition, ocrelizumab proved superior to the commonly used drug Rebif in reducing the annual rate of relapse of major symptoms and other measures of the status of the disease, Roche said in a news release.
“The results of these three pivotal trials have the potential to transform the treatment of Mississippi”, explains Sandra Horning, M.D., who is the chief medical officer and head of Global Product Development for Roche.
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.
The disease either become progressively worse with age – or strikes in brutal, periodic relapses – with many people left relying on wheelchairs.
Ocrelizumab is a monoclonal antibody created to target a type of immune cell that may play a role in damaging myelin, the fatty tissue surrounding and protecting nerve fibers.
The results from that trial was presented last night at the European Committee for Treatment Research in Multiple Sclerosis conference in Barcelona.
Ocrelizumab is delivered twice-yearly via an intravenous drip.
The treatment is being described by experts as a “game-changer”.
Roche believes ocrelizumab’s potency and benign side effect profile make it unique, while industry analysts see it as a likely multibillion-dollar-a-year seller that will help the group diversify beyond its mainstay cancer business.
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.
Roche said it plans to submit the results from the trials to the U.S. Food and Drug Administration in early 2016, as it seeks marketing approval to treat both forms of Mississippi. The trials were conducted by Roche’s biotech business, Genentech.
If it is approved as safe, and the United Kingdom health service then agrees to fund it, patients could get it on the NHS as soon as 2017.
The MS Society’s Executive Director for Policy and Research Nick Rijke said the results were a “big moment” in the search for an effective treatment.
Preliminary data from trials of 732 people showed that ocrelizumab slowed the onset of disability by 24% over the course of 12 weeks. The progression of their disability also slowed by 40 per cent.