Approvals

This marketing authorisation follows data from two phase 3 clinical trials assessing the drug in a 60mg dose once per day for the treatment of adult patients with episodic migraine in the ADVANCE trial and chronic migraine in the PROGRESS trial. Both trials met their primary endpoints of change from baseline in mean monthly migraine days across a 12-week period compared to placebo. The drug was generally well-tolerated, with the most commonly reported adverse events being nausea, constipation and fatigue/somnolence, the majority of which were mild. Belinda Byrne, medical director at AbbVie UK, added: “There is a common misconception that migraine is ‘just a headache,’ but for many patients, migraine has a devastating impact on their everyday life. AbbVie is committed to advancing the standards of care for people living with migraine and we are delighted that the MHRA has provided marketing authorisation for this new medication. We are currently working with the regulatory authorities to bring this potential treatment to eligible patients as soon as possible.”

Professor Peter Goadsby, honorary consultant neurologist at King’s College Hospital, commented: “Many patients struggle for years to find an effective treatment. During this time, many are resigned to living with the debilitating effects of migraine; it shouldn’t be this way. Atogepant is a new addition to the CGRP receptor antagonists (or gepants) treatment class and has shown promising results in clinical trials for the reduction of migraine and headache days. This marketing authorisation is an important step for the migraine community, increasing the range of treatment options that we can prescribe to them.”