This news has been selected as one of the 10 top neurology stories of 2016 by MedPage Today:
MedPage Today asked specialists in neurology around the country to tell us what they thought were the most important clinical developments in 2016. These were the five most commonly mentioned.
1. Ocrelizumab for Primary Progressive MS
Multiple sclerosis experts were hoping that a new drug that could treat not only relapsing MS, but also progressive disease, would be approved by the end of the year. That's not going to happen, since Genentech announced the FDA has pushed back the PDUFA date for ocrelizumab (Ocrevus) by 3 months as it reviews additional data on the company's manufacturing process.
But hopes are high that the B-cell-targeting drug will be the first to win approval for progressive MS. Although there are several treatments for relapsing disease, no other drug has ever been approved to treat the more aggressive form.
Updated findings from the OPERA and ORATORIO studies were presented at various meetings throughout the year, and drugmaker Genentech has continued to tout the 24% reduced relative risk of disability progression in primary progressive MS, although some have expressed concern that its effects in PPMS are not as strong as in RRMS.
"The excitement around the first effective therapy in PPMS is tempered by that benefit being predominantly in patients with active inflammation at the start of the trial, with little benefit seen among those without active inflammation at the start of the trial," said Robert Fox, MD, of the Cleveland Clinic. "To me, this trial suggests that patients with progressive MS and active inflammation may benefit from an anti-inflammatory therapy, but a treatment for the gradual, insidious progression seen in the majority of progressive MS patients remains elusive."
Jerry Wolinsky, MD, of UTHealth and Memorial Hermann in Houston, said that even if ocrelizumab isn't approved for PPMS, "the effects of the drug in relapsing forms of the disease are impressive, and have refocused the field into considering B cells as contributing more to the immunopathogenesis of the disease than we have in the past."