AbbVie gets European Commission nod for Aquipta for prophylaxis of migraine in adults

Chronic migraine is characterized by 15 or more headache days per month and at least eight migraine days, while episodic migraine refers to people with migraine who have less than 15 headache days per month. People living with migraine may experience frequent disabling attacks that prevent them from performing daily activities and can significantly affect their quality of life. This debilitating disease also imposes both a social and financial burden for people living with migraine and health care systems. In Europe, migraine is estimated to cost the economy €50 billion annually due to reduced productivity and workdays lost.

"The European Commission approval of AQUIPTA is a significant milestone for people suffering from four or more migraine days per month as it provides a once-daily treatment option that can reduce the number of migraine days and the associated pain they experience," said Roopal Thakkar, SVP, Development and Regulatory Affairs, Chief Medical Officer, AbbVie. "With this approval, AbbVie can help meet additional migraine patient needs through our enhanced portfolio of treatment options across migraine frequencies, including episodic and chronic migraine."

The approval of AQUIPTA is supported by data from two pivotal Phase 3 studies, PROGRESS and ADVANCE, which evaluated 60 mg once-daily (QD) AQUIPTA in adult patients with chronic migraine and episodic migraine, respectively. Both studies met their primary endpoint of a statistically significant reduction in mean monthly migraine days (MMDs), compared to placebo across the 12-week treatment period. Additionally, statistically significant improvements were seen in all secondary endpoints with AQUIPTA 60 mg QD, with a key secondary endpoint measuring the proportion of patients that achieved at least a 50% reduction in MMDs across the 12-week treatment period.

In the PROGRESS study, the changes from baseline in MMDs was a reduction of 6.8 days for AQUIPTA 60 mg QD and a reduction of 5.1 days for placebo (p=0.0024). The study demonstrated that 40% of patients treated with AQUIPTA 60 mg QD achieved at least a 50% reduction in MMDs, compared to 27% of patients in the placebo arm (p=0.0024).5 In the ADVANCE study, the changes from baseline in MMDs was a reduction of 4.1 days for AQUIPTA 60 mg QD and a reduction of 2.5 days for placebo (p≤0.001). The study also demonstrated that 59% of patients treated with AQUIPTA 60 mg QD achieved at least a 50% reduction in MMDs, compared to 29% of patients in the placebo arm (p≤0.0001).6

"Migraine is a neurological disease that causes recurrent pain and other migraine-associated symptoms, with attacks that can last several hours to days, leading to missed life opportunities," said Prof. Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall d'Hebron Hospital and Institute of Research, Spain. "The pivotal Phase 3 studies demonstrated AQUIPTA provides significant and sustained reduction of mean monthly migraine days. This allows people to experience relief with a simple to take once-daily tablet, including those who have had an insufficient response to prior preventative migraine treatments."

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