Acute Ischemic Stroke Guidelines Updated, Stephen Hahn Nominated for FDA, Satralizumab Reduces Risk of Relapse in NMOSD


Neurology News Network for the week ending November 9, 2019.

This week Neurology News Network covered an update to the 2018 guidelines for the early management of acute ischemic stroke, as well as the news surrounding a change of leadership at the FDA, with Stephen Hahn, MD expected to take over as the new commissioner, pending approval; Genentech's BLA was approved for satralizumab, a drug that proved effective in reducing risk of relapses in patients with neuromyelitis optica spectrum disorder (NMOSD).

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

The American Heart Association (AHA)/American Stroke Association (ASA) has issued an update to the 2018 guidelines for the early management of acute ischemic stroke, clarifying prior recommendations and taking into consideration new clinical trial data. The guidelines offer a comprehensive breakdown from symptom onset through 2 weeks poststroke. Ultimately, the guidelines include advice for prehospital care, urgent/emergency evaluation and treatment with intravenous and intraarterial therapies, as well as management during a hospital stay, such as secondary prevention measures to institute within 2 weeks. Additionally, the guidelines state their support for the use of stroke systems of care in both the prehospital and hospital settings.

According to reports, Stephen Hahn, MD, is expected to be named the new commissioner of the US Food and Drug Administration. If confirmed, Hahn, who is chief medical executive and a professor in the department of radiation oncology at The University of Texas MD Anderson Cancer Center in Houston, will take over from acting commissioner Norman Sharpless, MD, who stepped in to run the agency following the resignation of Dr. Steve Gotleib in April. While Hahn has found much success at MD Anderson, this agency post would be his first significant interaction with policy, according to a report from The New York Times. Notably, interim commissioner Sharpless will immediately return to his post as the director of the National Cancer Institute, while Brett Giroir, MD, an official with the Department of Health and Human Services, will step in as interim until Hahn is confirmed.

The FDA has accepted Genentech’s biologics license application for satralizumab based on findings from 2 phase 3 trials that showed effectiveness in reducing risk of relapses in patients with NMOSD. Satralizumab was previously granted breakthrough therapy designation for the treatment of NMOSD in December 2018. The double-blind, placebo-controlled studies evaluated the efficacy and safety of satralizumab over 96-weeks. Overall, 76.1% of patients assigned to satralizumab monotherapy in the SAkuraStar study were relapse-free at 48 weeks, compared to 61.9% who received placebo. At 96 weeks, 72.1% of patients who received treatment with satralizumab were relapse-free, compared with 51.2% of patients in the placebo group.

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