Inebilizumab for NMOSD, New Acute Migraine Clinical Trial End Points, Eptinezumab's Pending BLA for Migraine Prevention

This week, Neurology News Network covered the FDA granting a breakthrough designation to inebilizumab for neuromyelitis optica spectrum disorder, a recent review of new agency recommended end points for the acute treatment of migraine, and a conversation with Bob Azelby, MBA, CEO of Alder Biopharmaceuticals, about their pending launch of eptinezumab for migraine prevention, for which it recently had a BLA accepted for review (Transcript below).

Jenna:

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

The FDA granted a breakthrough therapy designation to inebilizumab, an anti-CD19 antibody previously known as MEDI-551, in development as a monotherapy for the treatment of neuromyelitis optica spectrum disorder, or NMOSD.

The rare, life-threatening autoimmune disease, which affects the central nervous system, is without an approved therapy or cure, making the development of this humanized monoclonal antibody a notably one. The designation was granted by the FDA based on the findings of the largest study ever conducted with monotherapy in NMOSD.

Findings from a recently completed review of a number of trials debuting the newest FDA-recommended end points for the acute treatment of migraine suggest the minimum number of patients needed to adequately power trials for statistical significance.

The study found that the use of the newly recommended co-primary end points—pain freedom at 2 hours posttreatment and freedom from most bothersome symptom other than pain at 2 hours posttreatment—can lower the required cohort sizes for statistical significance. All told, they found that roughly 180 subjects per arm can provide 80% power to significance.

If all goes according to the plans of Alder Biopharmaceuticals, its anti-CGRP migraine treatment, eptinezumab, will be entering commercialization in early 2020. However, the market it will be entering has become increasingly crowded, with 3 other CGRP-focused inhibitors granted FDA approval already.

Bob Azelby, MBA, chief executive officer of Alder, has expressed the company’s confidence in eptinezumab’s ability to provide patients advantages over its competing products. Most notably, in a number of statements, Azelby has touted eptinezumab’s design as focused specifically for “rapid, effective, and sustained suppression of migraine.” To find out more about the quarterly intravenous (IV) therapy, where it fits in the marketplace, and its potential to provide advantages to patients with migraine, NeurologyLive^® spoke with Azelby in an interview.

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.