Shionogi Filed for the New Drug Application of Baloxavir Marboxil in Taiwan for the Treatment of Influenza OSAKA, Japan, July 2, 2018 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that Shionogi filed the New Drug Application (NDA) of baloxavir marboxil in Taiwan for the treatment of influenza in patients 12 years of age and older on June 29, 2018. Baloxavir marboxil has a novel mechanism of action that inhibits cap-dependent endonuclease, an essential enzyme for viral replication. Baloxavir marboxil was approved in Japan on February 23, 2018 and is available under the brand name XOFLUZATM for the treatment of influenza Types A and B in adults and pediatric patients. 1 Clinical efficacy and safety data from a phase II study in Japan and a global phase III study (CAPSTONE-1) in otherwise healthy patients supported this NDA. Shionogi and F. Hoffmann-La Roche Ltd. (hereafter "Roche") are in a license and collaboration agreement to further develop and commercialize baloxavir marboxil. Under the terms of this agreement, Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan where the rights are retained exclusively by Shionogi. Shionogi is currently conducting a global Phase III study (CAPSTONE-2) in individuals at high risk for influenza-related complications. Shionogi's research and development efforts target infectious diseases as one of its priority areas, and Shionogi has positioned "protecting people from the threat of infectious diseases" as one of its core social missions. Shionogi strives constantly to bring forth innovative drugs for the treatment of infectious diseases, to protect the health of the many patients we serve.
2018/7/2 発表日：2018年7月2日塩野義製薬株式会社（本社：大阪市中央区、代表取締役社長：手代木 功、以下「塩野義製薬」または「当社」）は、バロキサビル マルボキシル（日本における製品名：ゾフルーザ(TM)）について、12歳以上の合併症のないインフルエンザウイルス感染症を適応症として、2018年6月29日に台湾食品薬物管理局（TFDA）に新薬承認申請を行いましたので、お知らせいたします。バロキサビル マルボキシルは、既存の薬剤とは異なる新しい作用機序であるキャップ依存性エンドヌクレアーゼ阻害作用でインフルエンザウイルスの増殖を抑制します。本薬は2018年2月23日に日本国内で製造販売承認を取得し、成人および小児におけるA型およびB型インフルエンザ感染症を対象に製品名ゾフルーザ(TM)として販売されております1。このたび、重症化および合併症を起こしやすいリスク要因を持たない健常のインフルエンザ患者を対象とした国内第II相臨床試験およびグローバル第III相臨床試験（CAPSTONE-1）における良好な有効性および安全性の結果をもとに、TFDAに新薬承認申請を行いました。本薬の開発および販売はF. Hoffmann-La Roche Ltd.（以下「Roche社」）との提携下で進めており、日本と台湾における本薬の販売は塩野義製薬が、それ以外の国における本薬の販売はRoche社が行います。現在、重症化および合併症を起こしやすいリスク要因を持つ患者を対象としたグローバル第III相臨床試験（CAPSTONE-2）を当社が実施中です。塩野義製薬は「創薬型製薬企業として社会とともに成長し続ける」ことを経営目標として掲げた中期経営計画SGS2020の中で、「世界を感染症の脅威から守る」ことを当社が取り組むべき社会課題の一つにあげております。人々の健康を守るために必要な感染症治療薬を、世界中の患者さまのもとにいち早くお届けできるよう、引き続き努力してまいります。なお、本件が2019年（平成31年）3月期の業績に与える影響はありません。
FDA grants priority review to novel flu antiviral June 27, 2018 Genentech announced that the FDA has accepted a new drug application and granted priority review for the company's single-dose, oral influenza treatment baloxavir marboxil. The investigational medication is designed to inhibit the cap-dependent endonuclease protein crucial for influenza virus replication, including in oseltamivir-resistant and avian strains, according to a news release. It is intended for patients aged 12 years and older with acute, uncomplicated influenza. Genentech said the FDA is expected to make a decision on the approval of baloxavir marboxil by Dec. 24. If approved, it would be the first influenza treatment with a novel mechanism of action in almost 20 years, the release said."The severity of the recent flu season underscores the need for new options beyond currently available treatments," Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release. "Baloxavir marboxil has been shown in clinical trials to decrease the duration of symptoms with one dose and demonstrated a significant reduction in viral shedding in just 1 day. We look forward to working with the FDA during the review process." The new drug application (NDA) is based on phase 3 data from CAPSTONE-1, a multicenter, randomized, double blind trial conducted in the United States and Japan. The trial compared the safety and efficacy of baloxavir marboxil with placebo or 75 mg of oseltamivir twice a day for 5 days in 1,436 patients aged 12 to 64 years with uncomplicated influenza. According to results presented at IDWeek, it was associated with a shorter duration of influenza symptoms compared with placebo — 53.7 hours vs. 80.2 hours (P < .0001) — and reduced the time to resolution of fever, which took 24.5 hours vs. 42 hours for placebo. There was no significant difference in the duration of symptoms or fever between the baloxavir marboxil and oseltamivir groups. In other results, the median time to the cessation of viral shedding was 24 hours in patients who received baloxavir marboxil, 72 hours in patients who received oseltamivir (P < .0001) and 96 hours in those who received placebo (P < .0001). In addition, baloxavir marboxil significantly reduced viral titers in the nose and throat from 24 hours through 120 hours compared with placebo, and at 24 hours and 72 hours compared with oseltamivir, the release said. In a safety analysis, baloxavir marboxil was well-tolerated and had a lower overall incidence of treatment-emergent adverse events (20.7%) compared with oseltamivir (24.8%) and placebo (24.6%). The most common adverse events reported by patients in the baloxavir marboxil group were diarrhea (3%), bronchitis (2.6%), nausea (1.3%) and sinusitis (1.1%). The NDA is also supported by data from a phase 2, placebo-controlled study in otherwise healthy patients with influenza, according to the release. Baloxavir marboxil will continue to be assessed during a phase 3 development program. Genentech said findings from the CAPSTONE-2 trial, which includes adult and pediatric patients at high risk for influenza complications, will be announced at a later date. The Roche Group, which includes Genentech, is developing baloxavir marboxil globally under an agreement with Shionogi & Co., Ltd., which discovered the treatment. Roche holds rights to baloxavir marboxil worldwide, except for in Japan and Taiwan. In these countries, rights to the antiviral are held exclusively by Shionogi. In February, the Japanese Ministry of Health, Labor and Welfare approved balaxovir marboxil for adult and pediatric patients with influenza types A and B. It is sold under the brand name Xofluza.
References: Genentech. FDA Grants Priority Review to Genentech's Baloxavir Marboxil for the Treatment of Influenza. https://www.gene.com/media/press-releases/14732/2018-06-25/fda-grants-priority-review-to-genentechs. Accessed June 26, 2018.
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