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Morningstar | Allergan’s Oral CGRP Liver Safety Study Results Confirm Positive Outlook

Wide-moat Allergan reported favorable top-line results for two safety studies of ubrogepant, its acute migraine oral CGRP product. Importantly, the company noted no drug-related liver issues from both trials, which has positive implications for ubrogepant as well as Allergan’s other oral CGRP in development for episodic migraine, atogepant. We’ll likely raise our year-end 2018 estimates since a generic version of Restasis has still not been approved, but we plan to leave our long-term forecasts and fair value estimate unchanged.

While we’ll have to wait to see more data behind the safety trials, the outcome seems to confirm our previous belief—based on isolated, but explainable liver enzyme issues in previous trials--that these oral CGRP products don’t have liver toxicity issues. We therefore stand by our thesis that the market continues to underappreciate Allergan’s pipeline, and approvals of both ubrogepant and atogepant would make Allergan first to market with oral CGRP products. Having completed previous phase 3 efficacy trials, management intends to file ubrogepant for approval with the U.S. Food and Drug Administration in the first quarter of 2019.