Ocrevus reduced all 3 aspects of relapsing MS disease: reduction relapses, reduction disability, and reduction lesions within the brain quite substantially.
“We’re excited that the FDA approved Ocrevus for both relapsing MS patients and primary progressive MS patients just 4 weeks ago,” said Hideki Garren, MD, Group Medical Director, Genentech & Roche Pharmaceuticals at AAN 2017.
The first approval for primary progressive MS patients who previously had no disease modifying treatment, ocrelizumab (Ocrevus), provides a new treatment for relapsing MS patients where there is a need for drugs that reduce disability progression. As an intravenous infusion, it’s only given once every 6 months, so patients only need to visit the doctor every six months for treatment.
According to Garren, the study results did support the team’s hypothesis that B-cells were central to the pathogenesis of MS. “As we published in the New England Journal, Ocrevus reduced all 3 aspects of relapsing MS disease: reduction relapses, reduction disability, and reduction lesions within the brain quite substantially.”
Garren explained that their label allows patients with relapsing MS and progressive MS to be treated. There are no restrictions on the type of RMS or PPMS that are treated, nor do they have a boxed warning.
Next on their radar are potential European approvals. Garren and team have been working closely with regulators to try to get this to European multiple sclerosis patients as quickly as possible. Additionally, as the first approval for Roche & Genentech in neuroscience in a long time, they’re “quite excited that this allows us to expand our investigation to other neurologic diseases.” In late-stage Roche, they have treatments that are being tested for Alzheimer’s disease, Autism, and for Spinal Muscular Atrophy.
Garren believes this makes a nice progression from when they published the data last year, to the FDA approval, and to the data showcased at AAN 2017. Specifically, their results highlighted that Ocrevus has a rapid onset of treatment in MS patients. “We also have additional data that shows we have an effect on fatigue (a very important aspect of MS, 75% of patients have fatigue). Finally we have our trials that are on-going in open-label, and we’re gathering more safety data, which shows consistency with the double-blind period.”