Aducanumab Not Recommended by FDA, White Paper on Mechanical Thrombectomy, Status Epilepticus Treatment FDA Approved

Neurology News Network for the week ending November 14, 2020.

This week Neurology News Network covered the FDA's Peripheral and Central Nervous System Drugs Advisory Committee decision to not recommend aducanumab for the treatment of Alzheimer disease, a white paper published which called for an increased use of mechanical thrombectomy, and the FDA approval of fosphenytoin sodium for injection for patients with status epilepticus.

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’s Peripheral and Central Nervous System Drugs Advisory Committee voted not to recommend regulatory approval of Biogen's aducanumab, in one of the most anticipated advisory committee decisions of the year.In the final vote, which assessed whether or not the findings from the EMERGE trial (Study 302)—in the context of information from studies 301, 302, 103, and pharmacodynamic data—could serve as primary evidence for the effectiveness of aducanumab in Alzheimer disease, the committee voted 10–0 (10 no; 0 yes; 1 uncertain) that the trial did not provide such evidence. In the final slide of the statistical review of aducanumab, the committee summarized that “at best, the evidence in this application is from [EMERGE] only and there exists compellingly conflicting phase 3 evidence,” noting that the approval of aducanumab could present challenges for other candidate therapies with regard to noninferiority, as well as issues with recruitment and retention for ongoing trials. They did acknowledge Biogen for its design of the clinical trials and its inclusion of biomarker-based data, as well as its subsequent effort to get the data on track for approval, calling for more collaboration between sponsors and the FDA in these processes.

A newly published white paper from the Society of Vascular and Interventional Neurology’s (SVIN) global initiative, Mission Thrombectomy 2020+ (MT2020+), has called for a push to increase the awareness, accessibility, and action for mechanical thrombectomy for patients with stroke worldwide.The SVIN group ultimately called for 2 main goals to be achieved. First, the implementation of public health interventions to double global access to mechanical thrombectomy treatments every 2 years for the next decade. Second, to perform 202,000 procedures worldwide by the end of 2020. Notably, MT2020+ pointed out that the burden of care for stroke extends beyond the United States, which is a global leader in mechanical thrombectomy use. All told, of the estimated 13 million people suffering strokes each year, 20% to 30% are caused by large vessel occlusion, making them eligible for—and highly treatable by—mechanical thrombectomy.

The FDA has approved fosphenytoin sodium for injection (Sesquient) from Sedor Pharmaceuticals for treatment of status epilepticus (SE) in adults and children.Currently, the injectable is the only room temperature-stable fosphenytoin approved for treatment of SE. Cerebryx is another fosphenytoin currently used to treat SE, but it requires refrigerated storage in the pharmacy which can create a delay between symptom onset and treatment. Neurocritical Care Society guidelines state that irreversible brain damage or death may occur if seizures are not stopped within 60 minutes of onset. The treatment allows for point-of-care storage and administration in first responder vehicles, emergency rooms, long-term care facilities, and others critical areas where prompt care is needed.

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