Allergan (AGN) Gets FDA Approval For Migraine Drug Ubrelvy
Zacks Investment Research | Dec 23, 2019 10:12PM ET
Allergan plc (NYSE:AGN) announced that the FDA approved a new drug application (NDA) for Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Ubrelvy is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks. It has been approved in two dose strengths — 50 mg and 100 mg.
Migraine is a neurological disease with episodic attacks defined by symptoms such as headache, sensitivity to light and sound, and nausea. With just one dose, this drug can quickly eliminate patients' migraine pain and symptoms compared with placebo at two hours.
The approval was supported by data from two pivotal phase III studies — ACHIEVE I & II — and two additional safety studies evaluating ubrogepant. The candidate demonstrated positive results in both pivotal studies, which evaluated it for the treatment of a single migraine attack.
Data from the additional safety studies demonstrated that ubrogepant was able to treat migraine patients who have an insufficient response to or are ineligible for treatment with triptan, one of the commonly used medications for migraine. Migraine patients with moderate-to-severe cardiovascular risk will also be eligible for treatment with ubrogepant.
The NDA for ubrogepant was accepted for review by the FDA in March. The FDA granted the application a normal review period of 10 months.
Shares of the company have surged 43.3% year to date compared with the Zacks Investment Research
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