THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced Wednesday 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 or CGRP-R, which is believed to play a critical role in migraine.
This is also the first independent submission and approval for Amgen K.K., an affiliate of Amgen Inc. headquartered in Tokyo.
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.
Migraine is a disabling neurological disease that affects more than 8.4 million people in Japan.
Aimovig's approval in Japan is based on results from a Phase II study evaluating the safety and efficacy of Aimovig in adult Japanese patients with episodic migraine, and a Phase III study 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 from baseline over months 4, 5 and 6 of the double-blind treatment period
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.
Copyright RTT News/dpa-AFX
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