The FDA Just Approved The First Drug For Aggressive Multiple Sclerosis

Genentech had some great news this week as the Food and Drug Administration has approved Ocrevus, the first drug for an aggressive kind of multiple sclerosis that steadily reduces the ability to walk and coordination.

The type of MS, called primary progressive MS, has not had any specific treatments for it as it is pretty rare. For the roughly 50,000 Americans diagnosed with it, the life span on average is shortened by six years, said Dr. Fred Lublin, director of the MS center at Mount Sinai Health System in New York City.

Genentech, part of Swiss drugmaker the Roche Group, is the company that developed the drug that is given intravenously every six months. The company said the initial list price without insurance will be $65,000 a year.

The study testing Ocrevus for primary progressive MS involved 732 patients.

According to Dr. Lublin, Ocrevus had a “modest but definite slowing effect on the rate at which people develop disabilities.”

Patients who received Ocrevus infusions had slower declines in walking ability and slow disability progression over nearly 2.5 years compared to the study participants who were given dummy infusions.

Ocrevus was also approved for relapsing forms of MS, which progresses more slowly.

It is estimated that 400,000 Americans have the relapsing-remitting type of MS, in which symptoms can wane for months and sometimes years before a flare up. This type has had several treatment options and since 1993, 14 drugs have been approved to slow it down.

“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,” said Dr. Billy Dunn, director of the FDA’s Division of Neurology Products, in a statement.

According to the FDA, the drug was also tested in two large studies that involved 1,656 patients as a treatment for relapsing forms of MS. In these 96-week studies, patients given Ocrevus had lower relapse rates and reduced worsening of disability compared to participants given Rebif, a standard drug for relapsing MS.

Genentech announced that Ocrevus will be available in the U.S. within two weeks.

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