AbbVie announced that the European Commission (EC) has approved AQUIPTA (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed (PRN). This approval is the second indication in the European Union (EU) for AQUIPTA, an oral Calcitonin Gene-Related Peptide (CGRP) receptor antagonist (gepant), which is now approved as both an acute treatment option for migraine attacks in adults and as a once-daily preventive treatment option for adults with chronic or episodic migraine who experience 4 or more migraine days per month.

Roopal Thakkar, MD, Executive Vice President, Research and Development, and Chief Scientific Officer (CSO), AbbVie, said, "The European Commission's approval of AQUIPTA is an important milestone for individuals requiring acute treatment for migraine. Clinical data have shown that AQUIPTA delivers fast and lasting relief for migraine attacks, including sustained pain freedom up to 48 hours. With this approval, AbbVie is able to address unmet needs for those living with migraine in Europe, offering a broad portfolio of acute and preventive treatments for chronic and episodic migraine."

Migraine is a prevalent and debilitating neurological disease, affecting roughly 14 percent of the global population, with a higher incidence in women than men. Especially common among individuals aged 25 to 55, migraine attacks can be characterised by severe, throbbing headaches, cognitive impairment, sensitivity to light and sound, and nausea, resulting in significant limitations on daily activities.

Uwe Reuter, MD, PhD, MBA, Professor of Neurology, Charité University Hospital, Berlin, Germany, and President of the European Headache Federation, said, "Migraine is an invisible disease that disrupts daily life, including meaningful time with friends and family, while also imposing significant mental, physical, and socio-economic burdens. The pivotal phase 3 study showed that AQUIPTA is an effective acute treatment option for migraine, and getting the right treatment can help clinicians better address the burden of this disease in people living with migraine."

The approval of AQUIPTA is supported by data from the phase 3 ECLIPSE study, which evaluated the efficacy, safety, and tolerability of AQUIPTA (60 mg) versus placebo for the acute treatment of migraine for a single attack and the consistency of effect across multiple attacks in adults with a history of migraine, with or without aura. The study met its primary endpoint, demonstrating that AQUIPTA was superior to placebo in achieving pain freedom at 2 hours after treatment of the first migraine attack (p<0.0001).

Additionally, the study demonstrated statistical significance versus placebo across several ranked secondary endpoints, including freedom from the most bothersome migraine symptom at 2 hours post-treatment, pain relief at 2 hours, reduced use of rescue medication within 24 hours, and sustained pain freedom from 2 to 48 hours (p<0.0001). AQUIPTA also demonstrated clinically meaningful and consistent effect across multiple migraine attacks.

During the 16-week, placebo-controlled, double-blind treatment period, AQUIPTA's safety profile was generally consistent with that observed in its approved indication for the preventive treatment of migraine. The most common adverse events were nasopharyngitis and upper respiratory tract infection.

AQUIPTA is also approved in the European Union (EU) as a once-daily CGRP receptor antagonist (gepant) for the prophylaxis (prevention) of migraine in adults with at least 4 migraine days per month.