The submission is based on 2 pivotal phase 3 studies evaluating the drug in adult patients with chronic and episodic migraines.
AbbVie submitted a marketing authorization application (MAA) to the European Medicines Agency for atogepant (Qulipta) for the prophylaxis of migraine in individuals who have at least 4 migraine days per month.
If approved, atogepant would be the first daily oral calcitonin gene-related peptide receptor antagonist for the prophylaxis of migraine for adult patients in Europe.
“Far too many people around the world are impacted from the debilitating challenges of migraine, which places a significant social and work-life burden for patients and care partners,” Michael Gold, MD, therapeutic area head of neuroscience development at AbbVie, said in a statement.
“At AbbVie, we are committed to advancing science to provide patients impacted by migraine with effective treatment options. If approved, atogepant will provide a prophylactic treatment option for adult migraine patients suffering for more than 4 days a month,” Gold said.
The application was supported by phase 3 trials, ADVANCE (NCT03777059)and PROGRESS (NCT03855137), evaluating the efficacy, safety, and tolerability of atogepant in patients with episodic migraine and chronic migraine, respectively.
The ADVANCE trial met its primary endpoint of a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared with the placebo. Investigators found this across all active treatment arms in the 10-, 30-, and 60-mg dosages once a day.
Additionally, the study results showed that a greater proportion of individuals treated with atogepant achieved at least a 50% reduction in mean monthly migraine days for all doses compared with the placebo and met other key secondary endpoints.
Individuals enrolled in the study met the International Classification of Headache Disorders criteria for a diagnosis of migraine with or without aura.
A total of 910 individuals were randomized to 1 of 4 treatment groups that evaluated the 3 dosages of atogepant once a day or the placebo. The efficacy analyses were based on the modified intent-to-treat population of 873 individuals.
The PROGRESS study also met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared with the placebo across the 12-week treatment period.
Furthermore, the trial also showed that treatment with atogepant 60 mg once a day and 30 mg twice a day resulted in statistically significant improvements in all secondary endpoints.
This includes the key secondary endpoint measuring the proportion of individuals who achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period.
In both studies, all doses were well-tolerated, and the overall safety profiles were generally consistent with the safety findings observed in previous studies for the prophylaxis of chronic and episodic migraine populations. The most common adverse events were constipation and nausea.
The Committee for Medicinal Products for Human Use will review the MAA and issue an opinion that will be valid for all member states of the European Union, as well as Iceland, Lichtenstein, Northern Ireland, and Norway.
AbbVie submits marketing authorization application to EMA for atogepant for the preventive treatment of migraine. News release. AbbVie. July 18, 2022. Accessed July 18, 2022. https://news.abbvie.com/news/press-releases/abbvie-submits-marketing-authorization-application-to-ema-for-atogepant-for-preventive-treatment-migraine.htm