AbbVie Receives Approval for Aquipta to Prevent Migraine Attacks in Japan

AbbVie’s New Migraine Treatment: Aquipta

AbbVie, a global biopharmaceutical leader, recently announced that it has obtained marketing approval in Japan for Aquipta(R) (generic name: Atogepant), aimed at preventing migraine attacks in adults. This promising development offers a new treatment option for individuals affected by migraine, a condition that significantly reduces productivity and limits social engagement.

The Impact of Migraine

Migraine is a debilitating condition that impacts over a billion people worldwide, with a reported prevalence of 8.4% among those over 15 in Japan. This neurological disorder not only disrupts daily life but also poses economic ramifications, especially among women under 50. It is identified as a primary source of social disability, leading to substantial workplace productivity losses. Symptoms include moderate to severe pulsating headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound.

When left untreated, migraine attacks can last anywhere from 4 to 72 hours, severely hampering daily activities, work, and social interactions. This condition can progress from episodic migraines, occurring fewer than 15 days a month, to chronic migraines with 15 or more headache days, resulting in an escalation of health issues over time. Current guidelines suggest that preventive therapy should be considered for patients experiencing more than two attacks per month or headaches that interfere significantly with their quality of life.

Approval and Clinical Trials

The approval for Aquipta was based on positive outcomes from domestic and international clinical trials. These included phase 2 and 3 studies conducted locally, as well as a global phase 3 trial. By offering Aquipta as a treatment, AbbVie aims to provide an effective way to suppress the onset of migraine attacks for adult patients. The drug is taken orally once a day, simplifying the administration for users.

In addition to this preventive indication, AbbVie plans to submit for approval for acute migraine treatment by December 2025.

Tiago Campos Rodrigues, President at AbbVie Japan, expressed his optimism regarding the approval, emphasizing that “the approval of Aquipta for migraine suppression provides hope for many patients suffering from this condition. Having a new treatment option enables better responses to diverse preventive needs, enhancing individual health and improving overall societal productivity and healthcare efficiency.”

Understanding Aquipta and Migraines

Aquipta belongs to a class of medications known as CGRP receptor antagonists, which are crucial in the management of migraine pathology. Research indicates that CGRP concentrations rise during migraine attacks, highlighting its role in the condition's physiology. Aquipta is already approved in over 60 countries as a preventive treatment for migraines, marketed as AQUIPTA(R) in the EU and QULIPTA(R) in the USA, Canada, Israel, and Puerto Rico.

Migraine affects approximately 14% of the global population, showcasing a higher prevalence among women than men. Migraines are most frequent in adults aged 25 to 55 and can lead to severe, pulsating headaches and accompanying symptoms such as sound and light sensitivity, often resulting in substantial disruption to daily activities. The economic burden of migraines is significant, with estimates indicating it accounts for 1.2% to 2.0% of GDP in Europe, showcasing the pressing need for effective treatments.

AbbVie remains dedicated to supporting migraine patients and is committed to advancing scientific knowledge and understanding in this field. Through awareness initiatives and collaborations with relevant organizations, AbbVie aims to ensure that patients can overcome barriers to treatment and receive the care they need to manage their condition effectively.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that address serious health issues. The company plays a pivotal role in tackling challenging health concerns, focusing on several key areas, including immunology, oncology, neuroscience, and eye care. For more information, please visit AbbVie’s official site or find them on various social media platforms including LinkedIn, Facebook, Instagram, and YouTube.