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Allergan's oral migraine drug wins US FDA approval

Allergan PLC's drug Ubrelvy was approved by the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults.

Migraine is a neurological disease characterized by intermittent recurring headache with symptoms that are often incapacitating. Migraine with aura is a recurring headache that strikes after or at the same time as sensory disturbances called aura, which can include flashes of light, blind spots and other vision changes or tingling in the hands or face.

The disease affects 31 million Americans and is the third-most common disease and second leading cause of disability worldwide, according to a Dec. 23 news release.

Ubrelvy, or ubrogepant, belongs to a group of medicines that work by blocking calcitonin gene-related peptides, or CGRPs, in the body to help prevent migraines, both chronic — those happening more than half the days in a month — and episodic, or those occurring less than half the days in a month but still relatively frequent.

Ubrelvy is the first and only orally administered CGRP receptor antagonist for the treatment of migraine attacks once they start. Other CGRP therapies approved in the U.S., such as Eli Lilly and Co.'s Emgality and Teva Pharmaceutical Industries Ltd.'s Ajovy, are injectables.

The approval for Ubrelvy is based on results from two phase 3 studies, called Achieve 1 and Achieve 2, which showed Ubrelvy was better at managing pain than placebo two hours after the initial dosage. Additionally, the drug provided relief to patients from symptoms of the condition such as nausea and hypersensitivity to light and sound.

Ubrelvy will be available in the U.S. in the first quarter of 2020.

The Dublin-based pharmaceutical company is also developing atogepant, another CGRP inhibitor, for reducing monthly headache days in adult patients with episodic migraines.