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アムジェンの片頭痛発作の発症抑制薬
「アイモビーグ®皮下注70mgペン」の在宅自己注射が保険適用に
日常生活に支障をきたす片頭痛患者さんの
治療と生活の質との両立を可能に
アムジェン株式会社（本社：東京、代表取締役社長：スティーブ・スギノ、以下「当社」）は本日、ヒト抗CGRP受容体モノクローナル抗体製剤「アイモビーグ®皮下注70mgペン」（一般名：エレヌマブ（遺伝子組換え）、以下「アイモビーグ」）が、厚生労働省の告示により、在宅自己注射指導管理料が算定可能な薬剤となり、9月1日から在宅自己注射の保険適用が認められることをお知らせします。
片頭痛は神経疾患のひとつで、成人の片頭痛発作は4〜72時間持続し、日常生活に支障をきたす原因として、世界的にも腰痛に次いで第2位となっています1。さらに片頭痛の好発年齢は若年から中年で、片頭痛は患者さんの日常生活への影響だけでなく、社会の経済的損失も引き起こしているとの報告もあります2,3。
アイモビーグは、2021年8月に発売された「片頭痛発作の発症抑制」を効能又は効果とする皮下注製剤で、4週間に1回、医療機関において皮下投与します。またアイモビーグはオートインジェクターというペン型の注射薬で、27ゲージという外形0.4mmほどの注射針で注射します。注射針は安全カバーでおおわれており、注射の際に針先が見えない構造になっており、在宅自己注射を必要とする患者さんが安心して投与できるよう設計・開発されました。
この度の保険適用に伴い、従来治療で日常生活に支障をきたしている患者さんにおいては、医師が適切と判断した場合、事前に十分な説明とトレーニングを受けていれば、在宅でのアイモビーグの自己注射が可能となります。これにより、片頭痛患者さんが「治療と生活の質との両立」を図るために、通院負担がより少ない治療選択肢を望まれるケースにも対応できることとなりました。
アムジェン株式会社では、「To serve patients –
患者さんのために、今できるすべてを」というミッションのもと、今後も片頭痛はコントロールが可能な疾患であることを、患者さんやそのご家族、社会に対して継続的に情報発信してまいります。
自己注射をされる患者さんへの情報提供について
医師の指導により自己注射を開始される患者さんが、より安全に安心してご使用いただけるよう、患者さんとご家族向けのウェブサイトに本剤の使い方解説動画などを公開しています。
アイモビーグによる治療を受ける患者さん向け情報サイト
自己投与について（9月1日公開予定）
https://www.aimovig-pts.jp/about/self-injection
片頭痛について
片頭痛は神経疾患であり4、中等度から重度の頭部痛の反復性発作を伴います。通常は拍動性で、しばしば片側性であり、悪心、嘔吐、光、音、匂いへの過敏症を伴います5。片頭痛は個人的な苦痛、障害、生活の質の低下、社会的・経済的コストと関連しています6。
個人の日常業務遂行能力を妨げるような深刻な影響を及ぼします。世界保健機関（WHO）の報告によると、片頭痛は男女ともに障害生存年数の原因疾患トップ2に数えられ7、未だ十分な理解と治療が施されていない可能性があります6,7。
アイモビーグについて
アイモビーグは、CGRP受容体を阻害することで片頭痛患者における片頭痛を予防できるように特異的にデザインされた完全ヒトモノクローナル抗体です。複数の臨床試験で本剤の安全性および有効性が検討されています。4,000人以上の患者が本臨床試験プログラムに参加しました。
アイモビーグは、米国食品医薬品局（FDA）、欧州医薬品庁（EMA）、スイスメディック（Swissmedic）、オーストラリア医療製品管理局（TGA）など、世界の多くの規制当局から成人の片頭痛予防薬として承認されています。
アムジェン株式会社について
アムジェン株式会社は、世界最大規模の独立バイオテクノロジー企業である米国アムジェン社の日本法人です。アムジェン株式会社では、循環器疾患、がん、骨疾患、炎症・免疫性疾患、神経疾患を始めとするアンメット・メディカル・ニーズが高い領域に焦点を絞り、現在約700人の従業員が、「To
serve patients – 患者さんのために、今できるすべてを」というミッションのもと、臨床開発から販売までの活動を行っています。詳細については
www.amgen.co.jp をご覧になるか、
https://www.facebook.com/amgenjapan をフォローしてください。
アムジェン社について
アムジェン社は、革新的な治療薬の発見、開発、製造、提供を通じて、重篤な疾患に苦しむ患者さんのために生物学の可能性を切り拓くことに取り組んでいます。このアプローチは、疾患の複雑性を解明し、人体の生物学上の基本を理解するために、先進的なヒト遺伝学などの手法を活用することから始まります。
アムジェン社は、アンメット・メディカル・ニーズが大きい領域に焦点を絞り、専門知識を活用して、医療効果を向上させ、人々の生活に画期的な改善をもたらすソリューションを追求しています。1980年に創業したバイオテクノロジーのパイオニアであるアムジェン社は、世界最大の独立バイオテクノロジー企業の一社に成長し、世界中の何百万という患者さんに貢献しており、革新的な可能性が期待されるパイプラインを開発しています。
アムジェンはダウ・ジョーンズ工業株価平均を構成する30社のうちの一社であり、ナスダック100指数にも含まれています。2021年には、Fortune and Great Place to
WorkTMからWorld’s Best WorkplacesTMの25社のうちの一社に、Barron’sから世界で最も持続可能な企業100社のうちの一社に選ばれました。
詳細については
www.amgen.com をご覧になるか、
www.twitter.com/amgen をフォローしてください。
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注意事項（アムジェン株式会社）
このニュースリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的とするものではありません。
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この件に関するお問い合わせ先
アムジェン株式会社（東京）
コーポレート・アフェアーズ
TEL 03-4563-8610
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[Last accessed: June 2021]. -
World Health Organization. Headache disorders. Available from:
http://www.who.int/mediacentre/factsheets/fs277/en/ [Last accessed: April 2020]. -
The Journal of Headache and Pain. Migraine facts. Available from:
https://thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-020-01208-0
[Last accessed: June 2021].
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