AbbVie's Atogepant Secures Positive CHMP Opinion For The Preventive Treatment Of Migraine

(RTTNews) - Biopharmaceutical company AbbVie Inc. (ABBV) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of European Medicines Agency has given a positive opinion on the approval of Atogepant for the preventive treatment of migraine in adults.

If approved by the European Commission, the company will be the only one to offer a daily once oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment spanning both episodic and chronic migraine in the European Union.

The positive opinion on the drug is based on the results from two pivotal Phase 3 studies evaluating Atogepant for the prophylaxis of migraine in adults with episodic or chronic migraine. Both studies met their primary end point with a reduction in mean monthly migraine days compared to the placebo in the 12-week treatment period.

Atogepant is already approved in the U.S. under the brand name Qulipta, to prevent episodic and chronic migraine.

Chronic migraine has the characteristics of more headache days a month with at least eight migraine days. Episodic migraine refers to people who have less than 15 headache days per month.

Migraine is estimated to cost the economy 50 billion euros annually due to reduced productivity and lost workdays in Europe. It is very prevalent and affects around one billion people globally, including an estimated 41 million people in Europe.

In premarket activity, shares of AbbVie are trading at $137.10, down 0.23% or $0.31 on the New York Stock Exchange.