FDA Approves Shorter-Infusion Ocrelizumab, StrokeViewer Cleared by FDA, Ezogabine Demonstrates Efficacy in ALS

December 19, 2020
NeurologyLive Staff

Neurology News Network for the week ending December 19, 2020.

This week Neurology News Network covered the FDA approval of the shorter 2-hour infusion time for ocrelizumab for patients with relapsing or primary progressive multiple sclerosis, the FDA clearance of Nico.Lab's StrokeViewer LVO, and the phase 2 study of ezogabine in patients with amyotrophic lateral sclerosis.

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.

The FDA has approved a shorter 2-hour infusion time for ocrelizumab (Ocrevus; Genentech), dosed twice-yearly for patients with relapsing or primary progressive multiple sclerosis who have not experienced any prior serious infusion reactions. The basis for the approval was from the randomized, double-blind ENSEMBLE PLUS study, a prospective substudy to the open-label, single-arm, phase 3b ENSEMBLE trial. Results showed a similar frequency and severity of IRs for a 2-hour ocrelizumab infusion time compared to the previously approved 3.5-hour time in patients with relapsing-remitting MS. The FDA accepted the supplemental biologics license application (sBLA) for the shorter infusion ocrelizumab in April. Ocrelizumab was approved as the first of its kind treatment of primary progressive MS in 2017. In January, the FDA updated the drug’s label with new safety information, including additions to the possible infusion-related reactions and information regarding the need for immunizations, revisions to pregnancy risk summary, and updates to the Patient Counseling section.

Nico.Lab’s StrokeViewer LVO, an artificial intelligence (AI) algorithm that detects image characteristics associated with large vessel occlusion, had its 510k application approved by the FDA for the fast triage of patients with stroke.The decision was based on results from a clinical study where the performance of the algorithm was retrospectively evaluated in 284 patients from multiple US stroke centers. An assessment of the data, which identified LVOs (ICA, M1, and M2) and compared them to the algorithm, exceeded the performance goal, according to an expert panel. StrokeViewer LVO is a cloud-based solution that uses AI to support physicians in the emergency stroke setting by sending a notification to medical specialists minutes after a patient with stroke has arrived at the hospital. At that point, physicians are able to use their smartphones, both at an in-hospital and at-home setting, to inspect the computerized tomography (CT) scans images in a web viewer and diagnose stroke.

Newly published data from a phase 2 randomized controlled trial of patients with amyotrophic lateral sclerosis (ALS) demonstrated that treatment with ezogabine decreases cortical and spinal motor neuron (MN) excitability, which may suggest that neurophysiological metrics may be used as a pharmacodynamic biomarker in future clinical trials. Investigators used change in short-interval intracortical inhibition (SICI) as a primary outcome among 65 patients who were randomized to either placebo, 600 mg/day of ezogabine, and 900 mg/day of ezogabine for a 10-week study period. In the 900-mg/day ezogabine group, the SICI-1 increased by 53% compared to the placebo group. However, the SICI-1 did not change in the 600-mg/day ezogabine group vs the placebo group.

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