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

DOI: https://doi.org/10.1007/s40265-020-01300-4

Abstract-Summary Eptinezumab, delivered by intravenous (IV) administration, is being developed by Lundbeck Seattle BioPharmaceuticals for the prevention of migraine.

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4 Treatment

In February 2020, eptinezumab was approved in the USA for the preventive

treatment of migraine in adults.

This article summarizes the milestones in the development of eptinezumab lead-

ing to this first approval.

Introduction It is being developed by Lundbeck Seattle BioPharmaceuticals, Inc. for the preven- tion of migraine and has received its first approval in the USA [162] for the preven- tive treatment of migraine in adults [163].

This article summarizes the milestones in the development of eptinezumab lead-

ing to this first approval for the preventive treatment of migraine.

Eptinezumab is also under regulatory review in Canada for the preventive treat- ment of migraine, and Lundbeck plans to submit regulatory applications for approval in the EU and other regions of the world, including China and Japan [162].

Lundbeck Seattle Biopharmaceuticals, Inc. (formerly known as Alder Biopharmaceuticals, Inc.) owns, or co-owns with exclusive rights, four patent fami- lies related to eptinezumab.

Under the terms of the agreement, Alder received a non-exclusive license to Teva’s CGRP patent portfolio for the development, manufacturing and commercial- ization of eptinezumab in the US and worldwide, excluding Japan and South Korea.

Scientific Summary In an exposure–response analysis based on data from three placebo-controlled stud- ies (n = 2543) of single-dose eptinezumab 10–300 mg, an area under the plasma concentration–time curve (AUC) from 0 to 12 weeks of ≥15,000  h μg/mL (≥100 mg) produced a sustained decrease in mean monthly migraine days (MMDs) over weeks 1–12 relative to baseline [164].

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A single dose of eptinezumab 100 mg significantly (p = 0.031) reduced the mean number of migraine headache days in weeks 5–8 relative to placebo (primary end- point; mean change from baseline −5.6 vs −4.6; baseline ≈ 8.6 days).

In PROMISE-1 in patients with EM, treatment-emergent adverse events (AEs) occurred in 58–63% of patients across treatment groups (eptinezumab 30, 100 or 300 mg and placebo groups; total n = 219, 223, 224 and 222) [165].

Acknowledgement A machine generated summary based on the work of Dhillon, Sohita. 2020 in Drugs.

Atogepant: First Approval