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Allergan seeks US FDA approval for migraine treatment

Allergan PLC said the U.S. Food and Drug Application accepted its application seeking approval for ubrogepant for the acute treatment of migraine in adults.

The new drug application is based on two phase 3 studies, called Achieve 1 and Achieve 2, and two additional safety studies. The regulator is expected to decide ubrogepant's approval in the fourth quarter of 2019.

Statistically significant results from the late-stage trials showed that both 50 milligram and 100-milligram doses of ubrogepant were better at alleviating pain and bothersome symptoms of migraine compared to placebo.

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 less than half a month but still relatively frequent.

Ireland's Allergan is vying to sell the first oral CGRP therapy to treat migraine in the U.S. Other CGRP therapies like Eli Lilly and Co.'s Emgality and Teva Pharmaceutical Industries Ltd.'s Ajovy, which are approved in the U.S., are injectable versions of the medicine.