FDA Approves Ofatumumab, EVT Effective in Late Presenting Stroke, Rimegepant Safe With CGRP Antibodies


Neurology News Network for the week ending August 29, 2020.

This week Neurology News Network covered the FDA approval of ofatumumab for patients with relapsing forms of multiple sclerosis, results from a study of patients with anterior circulation large vessel occlusion presenting very late from their last well known time who received endovascular treatment, and the safety of rimegepant with preventative CGRP.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Novartis has announced that the FDA has granted market approval to ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS. The subcutaneous injection therapy is a precision targeted B-cell agent administered once monthly at home via the Sensoready autoinjector pen. Novartis noted that it anticipates the therapy to become available in the US as early as September, with additional regulatory submissions ongoing and expected approval in Europe by the first half of 2021. Stay tuned for our pipeline update for more information about the drug approval.

Results from a case-control study suggest that patients with anterior circulation large vessel occlusion presenting very late from their last well known time may still benefit from endovascular treatment, despite previous notions of the therapy only being effective during a window less than 16 to 24 hours from time last well known. Of the included 150 patients who had an acute ischemic stroke with internal carotid artery or middle cerebral occlusion and arrived 16 hours or more from time last well known, 24 (16%) received EVT. A modified Rankin Scale score of 0 to 2 at 3 months after score occurred in 55 patients (37%)—13 of 24 patients who received EVT (54%) and 42 of 126 patients who received medical treatment (33%). EVT was associated with better odds of a 90-day mRS of 0 to 2 as were the odds of having a favorable 90-day mRS score shift.

New safety data published in Headache suggest that rimegepant, a recently FDA-approved agent for the acute treatment of migraine, can be safely administered in tandem with the preventive monoclonal antibodies against calcitonin gene-related peptide. At least 1 on-treatment adverse event was reported by 38%, after a mean 4-week exposure of 7.8 doses. Of those, 15% of the patients had mild or moderate nasopharyngitis; no other AEs occurred in ≥2 patients. Possible treatment-related AEs of mild to moderate severity— viral gastroenteritis, first‐degree atrioventricular block, and dizziness—occurred in 23% of patients. Notably, no patients had serious AEs, AEs leading to discontinuation, or aminotransferase levels >3 times the upper limit of normal. Of the 12 patients with liver function test data, 1 patient had an AST level that was above normal. Study author Gary Berman wrote, “Although not specifically studied, the mechanism(s) that might underlie the therapeutic benefit of oral rimegepant acute treatment combined with injectable CGRP monoclonal antibody preventive therapy are of interest.”

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