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.

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.

FDA commissioner Scott Gottlieb has resigned, tendering his resignation to Health and Human Services Secretary Alex Azar in a letter. The news of his resignation comes as a relative surprise.

Just 2 months prior, he noted on his Twitter account that he wanted to be very clear that he was not going to leave the FDA. “We’ve got a lot of important policy we’ll advance this year," he wrote.

Eli Lilly announced that the FDA granted priority review for its supplemental biologics application for its galcanezumab (Emgality) injection for the preventive treatment of episodic cluster headache in adults.

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.

The findings of a recent study have shown that neurologists have clearly and persistently deviated from the readily available scientific evidence regarding the utilization of DMTs for the treatment of MS.

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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