Allergan Gets FDA Approval for Migraine Treatment

Health and Healthcare

Published: December 24, 2019 7:55 am

Last Updated: January 30, 2020 11:52 am

The U.S. Food and Drug Administration (FDA) on Thursday announced that it had approved ubrogepant tablets in dosages of 50 mg and 100 mg for the immediate treatment of migraine in adults. Allergan PLC (NYSE: AGN) makes and markets the treatment under the brand name Ubrelvy. It is the first FDA-approved treatment in its class for acute migraine.

Migraine affects some 37 million Americans, is three-times more common in women than in men, and affects more than 10% of people all over the world. The condition causes intense throbbing or pulsating headache pain in one area of the head and includes symptoms such as nausea, vomiting and sensitivity to light and sound. About a third of sufferers also experience aura, a sensory phenomenon or visual disturbance that can appear as flashing lights, zigzag lines or a temporary loss of vision. Ubrelvy treats migraine that occurs with or without aura.

The drug is one of the most valuable projects in Allergan’s product pipeline. Data from two safety trials provided “no signal of drug-induced liver injury or hepatic safety concern,” according to an Evaluate report. In both studies, the FDA reported, “significantly” more patients treated with Ubrelvy experienced less or no pain and symptomatic relief two hours after treatment.

Allergan plans to launch the product in the first quarter of 2020 and is forecast to post sales of $302 million annually in 2024.

A similar drug from Biohaven Pharmaceutical Holding Co. Ltd. (NYSE: BHVN), rimegepant, is expected to report safety data in the first quarter. Biohaven submitted its New Drug Application for the treatment in July of this year.

In May of 2018, the FDA approved Amgen Inc.’s (NASDAQ: AMGN) Aimovig, the first treatment designed to prevent migraine. Eli Lilly and Co. (NYSE: LLY) received approval for its migraine treatment Reyvow in October of this year, and Emgality, a migraine preventative, was approved in June. Reyvow is similar to Ubrelvy but treats a different class of receptor agonists.

Allergan is expected to close its $86.3 billion merger with AbbVie Inc. (NYSE: ABBV) early in 2020, one of the biggest mega-mergers of 2019.