AbbVie has announced the approval of Aquipta (atogepant) by the European Commission for the preventive treatment of migraine in adults who experience four or more migraine days per month. Aquipta is noteworthy as the first and sole once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (atogepant) available within the European Union (EU) for the prevention of migraine.
The authorization is grounded in the results of two pivotal Phase 3 trials, PROGRESS and ADVANCE. These trials showcased a statistically significant reduction in the mean monthly migraine days when treated with Aquipta compared to placebo among adult patients with chronic and episodic migraine.
With this approval, AbbVie's therapeutic offerings for adult patients with varying migraine frequencies, encompassing episodic and chronic migraines, have been further expanded. AbbVie has heralded this milestone as AQUIPTA secures its position as the pioneering once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist treatment in the European Union, catering to the preventive treatment of both chronic and episodic migraine cases.
Chronic migraine is characterized by more than 15 headache days per month, at least eight of them being migraine days, whereas episodic migraine is defined as those with fewer than 15 headache days monthly. The debilitating impact of migraine can hinder daily activities and significantly compromise the quality of life for affected individuals. The toll of this condition extends to both social realms and financial implications, posing a burden on patients and healthcare systems. In Europe, the economic toll of migraine amounts to approximately €50 billion annually due to productivity loss and missed workdays.
The approval of Aquipta is substantiated by data derived from two pivotal Phase 3 studies, namely PROGRESS and ADVANCE. These studies evaluated the efficacy of Aquipta 60 mg once daily (QD) in adult patients with chronic and episodic migraine, respectively. Both trials successfully met their primary endpoint, exhibiting a statistically significant reduction in mean monthly migraine days (MMDs) over the 12-week treatment period compared to the placebo.
Key findings from the trials include:
In the PROGRESS study involving chronic migraine patients (n=778), the change from baseline in MMDs showed a reduction of 6.8 days for Aquipta 60 mg QD, compared to a decrease of 5.1 days for the placebo. Notably, 40% of patients treated with Aquipta 60 mg QD achieved a minimum 50% reduction in MMDs, compared to 27% of the placebo group.
The ADVANCE study focused on patients with episodic migraine (n=910). In this group, the change from baseline in MMDs demonstrated a reduction of 4.1 days for Aquipta 60 mg QD, compared to a decrease of 2.5 days for the placebo. This study also highlighted that 59% of patients treated with Aquipta 60 mg QD achieved a minimum 50% reduction in MMDs, compared to 29% of patients in the placebo arm.
The safety profile of Aquipta 60 mg QD proved manageable and consistent with earlier findings. Common adverse events included constipation (8%), nausea (9%), and fatigue (5%), with the most frequent adverse drug reaction leading to study discontinuation being nausea (0.4%).
The Phase 3 PROGRESS trial enrolled 778 patients with chronic migraine and evaluated the safety, tolerability, and efficacy of oral atogepant compared to placebo. The study involved different dosages and demonstrated a significant reduction in mean MMDs for the 60 mg QD dosage over 12 weeks. The Phase 3 ADVANCE study encompassed a participant pool of 910 individuals experiencing 4 to 14 migraine days per month. This trial illuminated advancements evident in primary and secondary endpoints, all achieved by administering the 60 mg QD dosage.
The successful approval of Aquipta marks a notable advancement in the treatment landscape for migraine, providing a promising option for patients grappling with this debilitating condition.