Thursday, June 24, 2021
Amgen announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig® (erenumab) for the suppression of onset of migraine attacks in adults. Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.3 This is also the first independent submission and approval for Amgen K.K., a wholly owned affiliate of Amgen Inc. headquartered in Tokyo.
"Today's approval further strengthens Amgen's commitment to the migraine community, and we continue to look for ways to expand the availability of Aimovig to help more patients," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "We've seen how much Aimovig has already helped many people living with migraine around the world. Having this treatment approved in Japan will enable us to ultimately serve more patients and help them find the right treatment for this disabling, neurological disease."
Aimovig's approval in Japan is based on results from a Phase II study (20120309) evaluating the safety and efficacy of Aimovig in adult Japanese patients with episodic migraine, and a Phase III study (20170609) evaluating the efficacy and safety of Aimovig in adult Japanese patients with episodic and chronic migraine. In both studies, Aimovig significantly reduced monthly migraine days (MMD) from baseline over months 4, 5 and 6 of the double-blind treatment period (DBTP).5,6 The safety and tolerability of Aimovig was also consistent with previously available global data. The most commonly reported adverse reactions include constipation, injection site reactions and somnolence at an incidence of 1% or more.5,6
"We were impressed by the Japanese Phase III study (20170609) that showed patients treated with Aimovig saw a reduction from baseline in their monthly migraine days," said Koichi Hirata, M.D., vice president, Dokkyo Medical University. "We believe Aimovig will bring renewed hope to patients by enabling fewer monthly migraine days, and that it will become one of the preferred treatments given its long-term safety and efficacy data."
Migraine is a debilitating neurological condition and can have significant impact on many areas of a person's life.1,7 Although approximately 8.4 million people in Japan suffer from migraine, most tend to try and endure the symptoms without seeking help from medical professionals.2,8 In Japan, more than 70% of patients with migraine have never visited a hospital to treat their disease, and about 50% of patients try to treat their disease on their own with over-the-counter medications.8
"Migraine is a serious neurological disease, yet is poorly understood in Japan as a condition that requires proper treatment," said Steve Sugino, general manager, Amgen K.K. "We want patients to know they don't need to push through this disease alone. If properly treated with a therapy like Aimovig that has proven efficacy and has an established tolerability profile, they may be able to take on day-to-day tasks and challenges they had previously been forced to give up."
Aimovig (erenumab-aooe) was approved as a preventive treatment for migraine in adults in the United States on May 17, 2018. As of May 2021, it has been approved in 71 countries or territories, including the European Union, the United Kingdom, Canada, and Australia, and is approved by many regulatory authorities worldwide. In Japan, Aimovig will be administered subcutaneously in a clinical setting at a dose of one injection every four weeks, consistently from first dose to continuous administration, and likewise after resuming from interruption.
Amgen K.K. became a wholly owned affiliate of Amgen Inc. in the U.S. in April 2020. It has been co-developing and marketing products in the cardiovascular, oncology, bone, inflammation, neuroscience, and other disease areas, with Aimovig becoming its first independently developed product for patients in Japan.