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

DOI: https://doi.org/10.1007/s40265-021-01644-5

Abstract-Summary In September 2021, atogepant was approved in the USA for the preventive treat- ment of episodic migraine in adults.

4.2 Preventive Treatment

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This article summarizes the milestones in the development of atogepant leading

to this first approval for the preventive treatment of episodic migraine in adults.

Introduction One such agent is atogepant (Qulipta™), an orally administered, small-molecule, CGRP receptor antagonist [166] developed by AbbVie for the prophylaxis of migraine.

Atogepant is also in phase 3 clinical development for the preventive treatment of

chronic migraine in various other countries.

It is the first oral CGRP receptor antagonist developed specifically for migraine

prevention [167].

In July 2015, Merck entered into a licensing agreement with Allergan (prior to its acquisition by AbbVie) to divest the worldwide rights of the small-molecule CGRP receptor antagonists, atogepant and ubrogepant, with the latter responsible for the development, manufacture and commercialization of the products [168].

Scientific Summary There was a significantly (p < 0.001) greater least-squares mean (LSM) reduction from baseline in the mean number of migraine days per month (i.e. monthly migraine days; MMDs) with atogepant 10, 30 and 60 mg once daily (−3.7, −3.9 and −4.2, respectively; modified intent-to-treat [mITT] n = 214, 223 and 222) than with placebo (−2.5; mITT n = 214) over the 12-week treatment period (primary end- point) [mean MMDs at baseline were 7.5–7.9 across groups].

Each atogepant dosage regimen also provided significant (p < 0.001) benefit over placebo for the first four hierarchically-tested secondary endpoints, which included the LSM change from baseline in mean monthly headache days over the 12-week treatment period, the LSM change from baseline in mean monthly acute medication use days over the 12-week treatment period, the proportion of patients with a ≥50% reduction in the 3-month average of the mean MMD, and the LSM change from baseline in the role function-restrictive (RFR) domain score of the Migraine- Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) at week 12 [169].

Acknowledgement A machine generated summary based on the work of Deeks, Emma D. 2021 in Drugs.

Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review