AbbVie's AQUIPTA® (Atogepant) Granted European Commission Approval for Migraine Prophylaxis in Adults with Frequent Migraine Days

Thursday, August 17, 2023

AbbVie's recent announcement marks a significant milestone as the European Commission grants its approval for AQUIPTA® (atogepant). This approval is a breakthrough for individuals suffering from frequent migraines, particularly those who experience at least four migraine days each month. AQUIPTA, a unique once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), is now authorized for use within the European Union. This authorization encompasses both chronic and episodic migraine cases, expanding the array of available treatment options.

Chronic migraine, characterized by 15 or more headache days per month, with at least eight of them being migraine days, and episodic migraine, involving fewer than 15 headache days monthly, have profound impacts on daily life. They place significant social and economic burdens on individuals and healthcare systems. In Europe, migraine's toll on the economy is considerable, resulting in an estimated annual economic burden of €50 billion due to decreased productivity and missed workdays.

Dr. Roopal Thakkar, Senior Vice President of Development and Regulatory Affairs and Chief Medical Officer at AbbVie, stressed the significance of AQUIPTA's approval for individuals grappling with frequent migraine days. This newly approved treatment provides hope for reducing the frequency of these episodes and alleviating the associated pain. Dr. Thakkar also emphasized AbbVie's dedication to addressing various migraine frequencies, catering to both episodic and chronic cases.

The approval of AQUIPTA is grounded in robust data from two pivotal Phase 3 trials: PROGRESS and ADVANCE. These trials assessed the effectiveness of a 60 mg once-daily (QD) dose of AQUIPTA in adults dealing with chronic and episodic migraine, respectively. Both trials successfully met their primary goals by demonstrating a statistically significant reduction in mean monthly migraine days (MMDs) over a 12-week treatment period, compared to a placebo. Additionally, secondary endpoints were achieved with noteworthy enhancements in patients treated with AQUIPTA 60 mg QD, including the percentage of patients achieving a minimum 50% reduction in MMDs.

Findings from the PROGRESS study indicated a reduction of 6.8 days in MMDs with AQUIPTA 60 mg QD, in contrast to a reduction of 5.1 days with placebo (p=0.0024). Impressively, 40% of patients receiving AQUIPTA experienced a reduction of 50% or more in MMDs, while only 27% of the placebo group achieved this reduction (p=0.0024). The ADVANCE study revealed a reduction of 4.1 days in MMDs for AQUIPTA 60 mg QD, compared to a reduction of 2.5 days for placebo (p≤0.001). Furthermore, 59% of AQUIPTA-treated patients achieved a 50% or more reduction in MMDs, compared to 29% in the placebo group (p≤0.0001).

Notably, AQUIPTA 60 mg QD demonstrated a favorable safety profile in both trials. Common adverse events included constipation (8%), nausea (9%), and fatigue (5%), with nausea being the primary adverse drug reaction leading to study discontinuation (0.4%).

Dr. Patricia Pozo-Rosich, MD, PhD, Head of the Neurology Section at Vall d'Hebron Hospital and Institute of Research in Spain, emphasized the clinical importance of AQUIPTA's sustained reduction in mean monthly migraine days. She highlighted the advantage of AQUIPTA's once-daily tablet form, particularly for patients who have previously experienced inadequate responses to preventive migraine treatments.

It's worth mentioning that in the United States, Atogepant is marketed as QULIPTA® and is approved for both chronic and episodic migraine, while it is approved for episodic migraine in Canada.

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