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Amgen Announces Approval Of Aimovig® (Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults
Migraine is a Disabling Neurological Disease that Affects More Than 8.4 Million People in Japan[1],[2] Aimovig is the First and Only Approved Treatment in
About this update from Amgen Inc.
[{"type":"text","content":"Migraine is a Disabling Neurological Disease that Affects More Than 8.4 Million People in Japan[1],[2]\n Aimovig is the First and Only Approved Treatment in Japan to Block the Calcitonin Gene-Related Peptide Receptor (CGRP-R) That Plays an Important Role in Migraine[3]\n Aimovig Continues to be the Most Utilized Anti-CGRP Pathway Therapy, With More Than Half a Million Patients Prescribed Worldwide[4]\n\n\nTHOUSAND OAKS, Calif., June 23, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today 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. \n\"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.\"\nAimovig'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\n\"We were impressed by the Japanese Phase III study (20170609) that showed patients treated with Aimovig saw a reduction f...