AbbVie has made a significant stride in the realm of migraine management with the European Commission’s green light for Aquipta (atogepant). This novel medication has been granted approval for the prophylaxis of migraines in adults grappling with a formidable challenge – experiencing four or more migraine days per month. This landmark approval positions Aquipta as a trailblazer, as it becomes the sole once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment across the European Union. It’s poised to address both chronic and episodic migraine, setting a new horizon for preventive treatments.
Migraines, notorious for their debilitating impact, can become a daily struggle for those facing chronic migraine, which entails a staggering 15 or more headache days monthly along with at least eight migraine days. On the other hand, episodic migraine pertains to individuals with fewer than 15 headache days each month. The havoc these relentless attacks wreak on daily functioning and overall quality of life is profound, further exacerbated by the social and financial burdens they inflict on both migraine sufferers and healthcare systems. Europe bears the weight of an estimated ā¬50 billion annual economic toll due to decreased productivity and lost workdays attributed to migraines.
This game-changing nod for Aquipta is backed by compelling data hailing from two pivotal Phase 3 studies, namely PROGRESS and ADVANCE. These trials meticulously evaluated the efficacy of a 60 mg once-daily (QD) dosage of Aquipta in two distinct patient groups – those enduring chronic migraine and those dealing with episodic migraine. Encouragingly, both studies met their primary endpoint with a resounding reduction in mean monthly migraine days (MMDs) compared to placebo across the 12-week treatment period. In addition, a significant enhancement across all secondary endpoints was noted with AQUIPTA 60 mg QD, including a pivotal measure that gauges the proportion of patients achieving at least a 50% decrease in MMDs over the 12-week treatment span.
Delving into the specifics of the PROGRESS study, individuals on Aquipta 60 mg QD witnessed a remarkable reduction of 6.8 days in MMDs compared to 5.1 days with the placebo (p=0.0024). Furthermore, an impressive 40% of AQUIPTA-treated patients achieved a noteworthy 50% or more reduction in MMDs, while only 27% in the placebo group achieved the same (p=0.0024). In the equally impactful ADVANCE study, AQUIPTA 60 mg QD demonstrated a reduction of 4.1 days in MMDs versus 2.5 days for placebo (pā¤0.001). Here again, the medication displayed its prowess by driving 59% of patients towards a 50% or more reduction in MMDs, in comparison to a mere 29% in the placebo arm (pā¤0.0001).
The safety profile of AQUIPTA 60 mg QD was reassuring in both studies, with common adverse events including constipation (8%), nausea (9%), and fatigue (5%). Notably, the adverse event that led to discontinuation was predominantly nausea (0.4%).
Zooming in on the trials, the PROGRESS study engaged 778 patients grappling with chronic migraine, with three treatment groups receiving 60 mg QD of atogepant, 30 mg twice daily of atogepant, or placebo. The trial’s primary goal of decreasing mean MMDs compared to placebo for the 60 mg QD dose over a 12-week span was met (p=0.0024). On the safety front, the observed profile aligned with previous findings. Similarly, the ADVANCE study, encompassing 910 patients dealing with 4 to 14 migraine days per month, affirmed the efficacy of AQUIPTA 60 mg QD, resulting in statistically significant progress in primary and secondary endpoints.
The journey to this milestone has not been without side effects, with constipation (10%) and nausea (10%) emerging as the most frequent events in the PROGRESS study, while constipation (6.9%) and nausea (6.1%) took the lead in the ADVANCE study. Nonetheless, most cases were mild or moderate and did not necessitate discontinuation.
This approval signals a paradigm shift in migraine prevention, heralding new hope and relief for individuals grappling with this complex and often debilitating condition. AbbVie’s dedication to pioneering treatments shines brightly through Aquipta’s success, serving as a beacon for improved quality of life and enhanced productivity for those navigating the challenges of migraines.
