Demyelinisation of cells in multiple sclerosisThe United States Food and Drug Administration has just approved the humanized monoclonal antibody ocrelizumab (Ocrevus), aimed to treat both relapsing multiple sclerosis and primary progressive multiple sclerosis in adults.

The agency had originally expected the drug would be approved for RMS treatment but there was concern that it would not be effective for PPMS.  As such, this is now the first drug that has been approved, by the FDA, to treat PPMS.

“Multiple sclerosis can have a profound impact on a person’s life,” explains Billy Dunn, MD, who is the director of the Division of Neurology Products with the FDA’s Center for Drug Evaluation and Research. “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.”

Dunn goes on to say, “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.”

The Ocrevus test study for primary progressive multiple sclerosis involved 732 patients but did, in face, show a “modest but definite slowing effect on the rate at which people develop disabilities,” according to Dr. Fred Lublin, the director of MS center at Mount Sinai Health System, New York City.

When compared to placebo, patients who received Ocrevus infusions showed a slower decline in walking ability as well as slower progression of disability over 2.5 years.  The test group also showed fewer new, brain-damaging lesions development, though they did have a higher rate of specific side effects. These side effects can include (and are not necessarily limited to) upper respiratory tract infections and tumors.

But this drug was also tested in two large studies that involved more than 1,600 patients to investigate the drug as a potential treatment for relapsing forms of MS.  These studies were 96-weeks long and patients who received Ocrevus injections showed a lower relapse rate as well as reduced extension of the disability when compared to participants who received the standard relapsing MS drug, Rebif.

Jefferies LLC analyst Jeffrey Holford now forecasts that sales should peak at $5 billion a year.  He notes, “The results for the relapsing trial were more impressive, given that they were tested against an already approved therapy, but progressive disease is harder to study because it occurs so slowly. To see a significant benefit would take years, and this was only approximately a 2-year trial.”