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Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.
On June 23, 2021, Amgen announced that the Japanese Ministry of Health, Labor and Welfare granted marketing approval for Aimovig (erenumab) to suppress the onset of migraine attacks in adults, making it the first and only approved treatment in Japan to block the calcitonin gene-related peptide receptor (CGRP-R) believed to play a critical role in migraine. The approval also marks the first independent submission and approval for Amgen K.K., a wholly owned affiliate of Amgen Inc., headquartered in Tokyo, the company said in a press release.
Aimovig's approval in Japan is based on results from a Phase II study evaluating the safety and efficacy of the monoclonal antibody in adult Japanese patients with episodic migraine, and a Phase III study evaluating its efficacy and safety in adult Japanese patients with episodic and chronic migraine. In both studies, Aimovig significantly reduced monthly migraine days from baseline over months four, five, and six of the double-blind treatment period. The safety and tolerability of Aimovig was also shown to be consistent with previously available global data.
"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 in the company press release. "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."
"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, MD, vice-president, Dokkyo Medical University, in the press release. "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 serious neurological disease, yet is poorly understood in Japan as a condition that requires proper treatment," said Steve Sugino, general manager, Amgen K.K., in the press release. "We want patients to know they don't need to push through this disease alone. If properly treated with a therapy [such as] 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, the drug 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.