Abstract
Ubrogepant (Ubrelvy™) is an orally administered, small molecule, highly-selective, calcitonin gene-related peptide (CGRP) antagonist that was developed by Allergan under license to Merck & Co. as an acute treatment for migraine. In December 2019, ubrogepant received its first global approval in the USA for the acute treatment of migraine (± aura) in adults. This article summarizes the milestones in the development of ubrogepant leading to its first global approval for the acute treatment of migraine (± aura) in adults.
Highlights
Calcitonin gene-related peptide (CGRP), a vasodilatory neuropeptide involved in nociceptive transmission and modulation, and its receptors are widely expressed in central and peripheral regions of the nervous system [1,2,3]
Ubrogepant (UbrelvyTM), a highly potent, orally administered small molecule, is a CGRP receptor antagonist being developed by Allergan under license from Merck & Co., for the acute treatment of migraine [4]
1.1 Company Agreements In July 2015, Merck & Co. entered into a licensing agreement with Allergan to divest the worldwide rights of small molecule CGRP receptor antagonists, atogepant and ubrogepant
Summary
Calcitonin gene-related peptide (CGRP), a vasodilatory neuropeptide involved in nociceptive transmission and modulation, and its receptors are widely expressed in central and peripheral regions of the nervous system [1,2,3]. This profile has been extracted and modified from the AdisInsight database. Ubrogepant (UbrelvyTM), a highly potent, orally administered small molecule, is a CGRP receptor antagonist being developed by Allergan under license from Merck & Co., for the acute treatment of migraine [4]. On the 23 December 2019, the US FDA approved ubrogepant for the acute treatment of migraines (± aura) in adults [5]. It is the first drug in the class of oral CRGP antagonists approved for the acute treatment of migraine [5]. In patients with severe hepatic or renal impairment, the recommended dose is 50 mg; a second dose may be administered at least 2 h after the initial dose if needed [6]
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