Marketing authorization application to EMA submitted for atogepant for the preventive treatment of migraine
AbbVie announced it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month
The application is supported by the pivotal Phase III ADVANCE and PROGRESS studies evaluating the safety, efficacy, and tolerability of atogepant in adult patients with episodic migraine and chronic migraine, respectively.
Migraine is a complex neurological disease and one of the leading causes of disability worldwide. It is highly prevalent, affecting more than 1 billion people worldwide, including an estimated 11.4 percent of the population in Europe. If approved, atogepant would be the first daily oral CGRP receptor antagonist for the prophylaxis of migraine for adult patients in Europe.
The pivotal, Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial evaluated the efficacy, safety, and tolerability of once daily (QD) oral atogepant for the prophylaxis of episodic migraine. The study met its primary endpoint of a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared to placebo. This was found across all active treatment arms of atogepant – 10 mg, 30 mg, and 60 mg QD doses. The adult patients enrolled met the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of migraine with or without aura. The study also found that a greater proportion of atogepant-treated participants achieved at least a 50% reduction in mean monthly migraine days for all doses compared to placebo and met other key secondary endpoints.
The pivotal, Phase III, global, randomized, double-blind, placebo-controlled, parallel-group PROGRESS study, evaluating the safety, efficacy, and tolerability of oral atogepant in adult patients for the prophylaxis of chronic migraine, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. The trial also demonstrated that treatment with atogepant 60 mg once daily (QD) and 30 mg daily (BID), resulted in statistically significant improvements in all secondary endpoints. This includes a key secondary endpoint that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period.
In both, the Phase 3 PROGRESS and Phase 3 ADVANCE studies, all doses were well tolerated, and the overall safety profiles were consistent with safety findings observed in previous studies for the prophylaxis of episodic migraine and chronic migraine populations. The most common adverse events were constipation and nausea.
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