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Allergan to file for US approval of migraine drug after positive phase 3 studies

Allergan PLC said it will seek U.S. approval for its migraine drug ubrogepant in the first quarter of 2019 after two new phase 3 studies showed the drug was safe and tolerable.

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

Allergan said it expects ubrogepant to be 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.

The Irish pharmaceutical giant said that the phase 3 study, dubbed as UBR-MD-04, evaluated ubrogepant in doses of 50 milligrams and 100 milligrams to treat migraine in adults for one year. These patients had been enrolled in and completed one of the previous phase 3 studies: Achieve I or Achieve II.

The company said that both 50-milligram and 100-milligram doses were given to treat up to eight migraine attacks every fourweeks for one year, with patients having the option to take a second dose of the drug if they were unresponsive to treatment or if their migraine recurred.

Allergan said that of the 1,230 patients, about 76% of patients completed the 52-week treatment period with similar rates of completion across all the groups. Ubrogepant was well-tolerated with an adverse event profile similar to usual care arm in which patients used the medication that they routinely took to relieve a migraine attack.

In another phase 3 trial, known as 3110-105-002, ubrogepant was evaluated against a placebo in 516 healthy people. The trial was conducted on the recommendation of the U.S. Food and Drug Administration to study any risks to the liver that ubrogepant may cause.

The company said ubrogepant was well-tolerated with an adverse event profile similar to placebo and there were no signs of drug-induced liver injury or a liver safety concern.

Results from these two studies follow positive data from the Achieve I and Achieve II trials, which showed the effectiveness of the drug.