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AbbVie Seeks Approval for Atogepant in Japan

AbbVie, a biopharmaceutical company headquartered in Minato City, Tokyo, has announced its application for the manufacturing and sales approval of Atogepant, a CGRP receptor antagonist intended for the acute treatment of migraine attacks in adults. This application is based on data from international clinical trials, specifically targeting the needs of adult patients suffering from migraines.

Migraine is a prevalent condition, affecting over 1 billion people worldwide and around 8.4% of the adult population in Japan. The debilitating nature of migraines has significant impacts on patient productivity and leads to restrictions in social activities and daily life. Specifically, migraines are most commonly reported among women aged 30 to 40, with prevalence rates of approximately 20% and 18%, respectively.

The condition is characterized by moderate to severe throbbing pain, which can last between 4 to 72 hours, along with symptoms such as nausea, vomiting, and sensitivity to light and sound. These symptoms can be exacerbated by routine activities, often leading to substantial disruptions in daily life.

AbbVie's Efforts in Migraine Treatment

In light of recent advances in treatment options, AbbVie has made significant strides with the development of Atogepant, which not only aims to alleviate attacks but will also seek approval for the preventive treatment of migraines by March 2025. The approval application is supported by findings from the ECLIPSE trial, a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of Atogepant in treating acute migraines.

About Atogepant

Atogepant is a once-daily oral CGRP receptor antagonist designed specifically for the preventive treatment of migraines in adults. Research has shown that concentrations of CGRP increase during migraine attacks, indicating its role in the migraine's pathophysiology. Currently, Atogepant is approved for migraine prevention in over 60 countries, marketed as AQUIPTA® in the EU, and as QULIPTA® in the US, Canada, Israel, and Puerto Rico.

The Burden of Migraine

Migraine is a common and debilitating neurological disorder, affecting about 14% of the global population, with a higher prevalence in women than men. The impact of migraine attacks is most pronounced in adults aged 25 to 55, leading to significant challenges in everyday life, including severe pulsating headaches and reactions to light and sound. Moreover, the socioeconomic burden of migraines is staggering, as studies indicate that the loss attributed to migraines can represent 1.2% to 2.0% of GDP in Europe, disproportionately affecting women in unpaid labor roles compared to their male counterparts.

Despite the growing understanding of migraine's impact, the healthcare burden related to this condition has not significantly decreased over the past decade, underscoring an urgent need for effective treatment options.

AbbVie's Commitment to Patients

AbbVie continues its commitment to supporting migraine patients by innovating and enhancing treatment options. The company works closely with healthcare professionals to address the diverse needs of migraine sufferers while engaging in educational initiatives that empower patients to overcome treatment barriers and better manage their conditions.

About AbbVie

AbbVie’s mission is to develop and deliver innovative medicines that target current serious health challenges while tackling future medical issues. The company focuses on various key therapeutic areas, including immunology, oncology, neuroscience, eye care, and aesthetics. For more information about AbbVie, visit www.abbvie.com and find them on social media platforms like Facebook, Instagram, YouTube, and LinkedIn.