FDA Approves Galcanezumab for Episodic Cluster Headache, FDA Clears ReStore Exo-Suit for Stroke Rehabilitation, Alzheimer Disease May Be Influenced by LDL-C Levels

This week, Neurology News Network covered the FDA approval of galcanezumab (Emgality, Eli Lily) as the first therapy for the treatment of episodic cluster headache in adults, the FDA clearance to ReWalk Robotics' ReStore exo-suit intended for the treatment of gait impairments in stroke survivors, and the findings from an analysis that suggests that levels of low-density lipoprotein cholesterol, independent of APOE, are associated with early-onset Alzheimer disease—and that the APOB gene may play a role (Transcript below).

Jenna:

Welcome to Neurology News Network. I’m Jenna Payesko. Let’s get into the news from this week.

The FDA has approved galcanezumab, marketed as Emgality by Eli Lilly, as the first therapy for the treatment of episodic cluster headache in adults. The therapy was approved in its injection formulation, the same for which it was granted approval for preventive migraine treatment in September 2018.

The phase 3 trial included in the sBLA evaluated the safety and efficacy of 300-mg galcanezumab in 106 adults with episodic cluster headache. It was one of the first placebo-controlled studies performed in cluster headache, and demonstrated that injections of the study drug resulted in a statistically significant reduction in the frequency of cluster headache attacks compared with placebo in weeks 1 to 3 of the 2-month study period.

The FDA has granted clearance to ReWalk Robotics’ ReStore exo-suit intended for the treatment of gait impairments in stroke survivors. The device is the only soft exo-suit cleared by the FDA. The patented technology was originally developed at Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Data from a multi-center clinical trial launched in Spring 2018 was used to support ReStore’s 510(k) submission with the FDA. Results of that study, which enrolled 40 participants, are expected to be published later this year.

Findings from a series of case studies suggest an association between early-onset Alzheimer disease and elevated levels of LDL-C, independent of APOE. Additionally, the data showed the enhancement of rare coding variants of APOB in those with early-onset Alzheimer.

The investigators, led by Thomas S. Wingo, MD, of Emory University School of Medicine, noted that these APOB variants are a sign of the potential influence on plasma cholesterol levels, as the gene codes for the major protein of LDL-C, of which elevated levels indicate higher probability of early-onset disease. The analysis included more than 2000 plasma samples.

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