A machine generated summary based on the work of Markham, Anthony. 2018 in Drugs.

Galcanezumab: First Global Approval

DOI: https://doi.org/10.1007/s40265-018-1002-7

Abstract-Summary In September 2018, the US FDA approved galcanezumab as a once-monthly subcu- taneous injection for the preventive treatment of migraine in adults.

4.2 Preventive Treatment

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In the same month, the EMA issued a positive opinion for galcanezumab for the

prophylaxis of migraine in adults who have at least 4 migraine days per month.

This article summarizes the milestones in the development of galcanezumab

leading to its first approval for the preventive treatment of migraine in adults.

Introduction Galcanezumab (Emgality™), a humanized monoclonal antibody that selectively binds to and neutralizes calcitonin gene-related peptide (CGRP) [157], is being developed by Eli Lilly as a subcutaneous formulation for the preventive treatment of migraine and cluster headache.

Galcanezumab is undergoing phase III development for the preventive treatment of cluster headache in North America and Europe, and has been granted Fast Track Designation for cluster headache by the US FDA [158].

In January 2014, Eli Lilly announced that it had acquired all developmental and commercial rights for galcanezumab back from Arteaus Therapeutics, following a successful phase II proof-of-concept trial [159].

Eli Lilly had licensed the worldwide rights to develop galcanezumab to Arteaus

Therapeutics in October 2011 [159, 160].

Under the terms of this agreement, Arteaus Therapeutics in collaboration with Eli Lilly was to develop the antibody through phase II trials to demonstrate proof of concept in the prevention of migraine [160].

Scientific Summary Compared with patients receiving placebo, significantly greater proportions of patients receiving galcanezumab 120 or 240 mg achieved a ≥50% (62.3 and 60.9% vs. 38.6%), ≥75% (38.8 and 38.5% vs. 19.3%) or 100% (15.6 and 14.6% vs. 6.2%) reduction from baseline in monthly migraine headache days during treatment (p < 0.001 for all comparisons).

Relative to placebo, galcanezumab 120 and 240 mg (once-monthly) were associ- ated with significantly greater reductions from baseline in monthly migraine headache days (overall LSM change −4.8 and −4.6 vs. −2.7; p < 0.001 for both comparisons) during the 3-month double-blind treatment phase (primary endpoint) of the multina- tional phase III REGAIN trial (NCT02614261) in adults with chronic migraine [161].

Acknowledgement A machine generated summary based on the work of Lamb, Yvette N. 2018 in Drugs.

Eptinezumab: First Approval