AbbVie receives manufacturing and marketing approval in Japan for Aquipta (atogepant) for the prevention of migraine attacks

AbbVie announced that it has received marketing approval in Japan for Aquipta tablets (atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of migraine attacks in adult patients. According to the 2021 Japanese Clinical Practice Guidelines for Headache, preventive therapy should be considered for patients who experience two or more migraine attacks per month or at least three days per month of headache that significantly interferes with daily life. Amid expanding treatment options for migraine, AbbVie initiated development of Aquipta as an oral CGRP receptor antagonist. In March 2025, the company submitted a marketing authorization application in Japan for the prevention of migraine attacks and has now received approval. In addition, AbbVie submitted an application in December 2025 for the acute treatment of migraine attacks.

This approval is primarily based on results from: · i) A domestic Phase II/III study (M22-056)  ii) · A domestic Phase III study (3101-306-002) · iii) A global Phase III study (3101-303-002)

Tiago Campos Rodrigues, President of AbbVie GK, stated:

“The approval of Aquipta in Japan for the prevention of migraine attacks represents new hope for many patients suffering from migraine. By adding a new treatment option, we can better address diverse preventive treatment needs, potentially improving individual health and quality of life while contributing to increased societal productivity and more efficient use of healthcare systems.”