AbbVie Korea announced Thursday that Aquipta(atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, has been approved by the Ministry of Food and Drug Safty (MFDS) for the prevention of migraine in adults. This approval makes AQUIPTA the first once-daily oral CGRP receptor antagonist approved for the prophylactic treatment of chronic/episodic migraine in Korea, AbbVie said.
Chronic migraine is defined as 15 or more headache days per month with eight or more migraine days, while episodic migraine is defined as fewer than 15 headache days per month.
Migraine sufferers can experience attacks frequently that they are unable to perform daily activities properly, which can have a significant impact on their quality of life, the company said.
A survey of 207 migraine patients at neurology clinics in Korea found that migraine patients experienced headaches more than 12 days a month, and their learning or work performance was reduced by 50 percent due to headaches.
Despite the significant impact migraines have on daily life, it took an average of 10.1 years from symptom onset to diagnosis and an average of 3.9 visits to the doctor before finding their current doctor.
"As the first once-daily oral CGRP prophylaxis approved in Korea, AQUIPTA will provide a new treatment option for patients who are unwilling to take existing injectable medications," said Joo Min-gyeong, a professor of neurology at Severance Hospital.
"With this approval, AbbVie has built a diversified portfolio of migraine prophylaxis products that can be used to prevent a broader spectrum of migraines, from episodic to chronic migraines, and we will continue our efforts to meet the needs of migraine patients in the future," an AbbVie official said.
AbbVie's CGRP receptor antagonist, atogepant, was approved by the U.S. Food and Drug Administration (FDA) in 2021 for the prophylaxis of adult episodic migraine, and in April 2023, the FDA approved an expanded use for atogepant to include the prophylaxis of adult chronic migraine.