European Commission Approves AbbVie's AQUIPTA For Preventive Treatment Of Migraine In Adults

(RTTNews) - AbbVie Inc. (ABBV) on Thursday said the European Commission has approved its AQUIPTA (atogepant) for the preventive treatment of migraine in adults who have four or more migraine days per month.

The approval is based on two Phase 3 studies dubbed PROGRESS and ADVANCE, which evaluated AQUIPTA in adult patients with chronic migraine and episodic migraine, respectively. The company said that both studies met primary endpoint of statistically significant reduction in mean monthly migraine days (MMDs), compared to placebo across the 12-week treatment period.

Under the brand name QULIPTA, Atogepant is approved in the United States for both chronic and episodic migraine and in Canada for episodic migraine.

Chronic migraine is characterized by headache on at least 15 days per month, eight of these with migraine symptoms. Episodic migraine refers to headaches that occur in less than 15 days per month.