AbbVie has received approval from the European Commission (EC) for Aquipta (atogepant), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults, with or without aura.
This marks the second indication for Aquipta in the EU, where it is now approved both for acute attacks and as a once-daily preventive treatment for adults experiencing four or more migraine days each month.
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Migraine is a common and disabling neurological condition characterised by intense headaches, cognitive impairment, sensitivity to light and sound, and nausea, all of which can severely disrupt daily life.
The decision is supported by results from the Phase III ECLIPSE study, which assessed Aquipta (60mg) versus placebo for acute migraine treatment and its consistency across attacks.
The trial met its primary endpoint, showing Aquipta was more effective than placebo in achieving pain freedom at two hours after the first migraine attack treatment.
It also showed significant outcomes across key secondary endpoints, including relief of most bothersome symptoms and reduced use of rescue medication.
The study involved a 16-week double-blind period and reported the most frequent adverse events as nasopharyngitis and upper respiratory tract infections.
ECLIPSE was a randomised, 24-week, multi-centre, placebo-controlled, double-blind trial with an open-label extension conducted at 149 sites across China, the EU, Japan, South Korea, Taiwan, and the UK. It enrolled 1,328 adults with a history of two to eight moderate to severe migraine attacks per month.
AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar 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.”
Earlier this year, AbbVie announced plans to invest $380m to construct two new active pharmaceutical ingredient manufacturing facilities at its current North Chicago site in Illinois, US.
