The U.S. Food and Drug Administration has approved Roche's drug Ocrevus as treatment for the most severe form of multiple sclerosis (MS).
Ocrevus For Primary Progressive Multiple Sclerosis And Relapsing-Remitting Multiple Sclerosis
FDA's approval on Tuesday makes the drug the first U.S. approved medicine for the more severe type of the neurological disease called primary progressive MS, or PPMS, which accounts for 10 to 15 percent of all cases of MS.
Patients with PPMS experience gradual worsening of the neurological condition. The drug appeared to slow the progression of disease in patients with PPMS.
In a clinical trial involving more than 700 patients with PPMS, researchers found that those taking Roche's drug had 24 percent reduced risk of their disability progressing than the patients who were given placebo.
Health regulators also green-lighted the drug, known chemically as ocrelizumab, as treatment for the more common form of MS called relapsing-remitting multiple sclerosis (RRMS).
In another trial involving patients with RRMS, those who were given Ocrevus had 47 percent reduction in rate of relapses than the patients taking Merck & Co's Rebif, an older MS therapy.
"I think that this is a very big deal," said Stephen Hauser, from the University of California, San Francisco. "The magnitude of the benefits that we've seen with ocrelizumab in all forms of M.S. are really quite stunning."
Side Effects
Neurologist Dhanashri Miskin, from Lenox Hill Hospital in New York City, said that the side effects of the drug appear to be more reasonable than those of other drugs that are currently available as treatment for MS.
Despite this, health experts cautioned about the potential long-term safety of the medicine once it becomes widely prescribed. Natalizumab, which was approved by the FDA for multiple sclerosis years earlier, for instance, was initially found to be relatively safe but it was later found to carry small risk for a nerve-damaging virus.
"The drug looks to be incredibly safe for its efficacy," said Jerry Wolinsky, from the University of Texas in Houston. "Now the problem, to qualify things, is that natalizumab looked that way when it was approved. Time will tell whether other things will emerge."
Among the observed side effects of the treatment included upper respiratory infections, cold sores, and reaction at injection site.
How Ocrevus Works
The drug works by targeting a specific type of B cells, which appear to malfunction and play a role in central nervous system damage in individuals with MS. The immunosuppressive drug, which is set to be available in as short as two weeks, is given every six months.
Multiple Sclerosis
Multiple sclerosis is an autoimmune disease, a condition characterized by the body mistakenly attacking itself. It is estimated that over 400,000 people in the United States suffer from MS, 15 percent of whom have the more severe form.
The condition affects the spinal cord and the brain by damaging the myelin sheath, the material surrounding and protecting the nerve cells. Among its symptoms include muscle weakness, visual disturbances, body balance and coordination problems as well as thinking and memory problems.
