Gottlieb Resignation, Priority Review Granted to Galcanezumab for Prevention of Episodic Cluster Headache, Neurologists Treating MS Deviate From DMT Use
Neurology News Network for the week of March 9, 2019.
PUBLISHED March 09, 2019
This week, Neurology News Network covered the resignation of FDA commissioner Scott Gottlieb, the supplemental biologics application for Eli Lilly's galcanezumab injection being granted priority review by the FDA for preventive treatment of episodic cluster headache in adults, and the findings of a recent study that showed neurologists have deviated from scientific evidence regarding the utilization of DMTs for treatment of MS. (Transcript below)
Welcome to Neurology News Network. I’m Jenna Payesko.Let’s get into the news from this week.
The sBLA is backed by data from a phase 3 trial that evaluated the safety and efficacy of 300-mg galcanezumab injection in 106 adults with episodic cluster headache. In September 2018, it had been granted breakthrough designation therapy for the same indication.
Notably, in secondary progressive disease and primary progressive disease, the use of DMTs was considerable—contrary to the recommendations of the evidence-based guidelines—going from 47.2% to 51.5% over 9 years in secondary progressive MS and from 36.4% to 34.3% in primary progressive MS.
Investigators wrote that, “Our data suggest that prescribers were not aware of or were not following evidence-based guidelines for individuals with non-relapsing courses of disease, over age 54, and severe disability.”
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