Maruyama, Shoichi
Ikeda, Yoichiro
Kaname, Shinya
Kato, Noritoshi
Matsumoto, Masanori
Ishikawa, Yumiko
Shimono, Akihiko
Miyakawa, Yoshitaka
Nangaku, Masaomi
Shibagaki, Yugo
Okada, Hirokazu
Funding for this research was provided by:
Alexion GK
Nagoya University
Article History
Received: 27 August 2023
Accepted: 10 February 2024
First Online: 29 May 2024
Declarations
:
: S. Maruyama received honoraria for lectures and participation on advisory board from Alexion Pharma GK. S. Kaname received honoraria for lectures and participation on advisory board from Alexion Pharma GK. M. Matsumoto received honoraria for lectures and participation on advisory board from Alexion Pharma GK. Y. Miyakawa received research grant, clinical trials, and honoraria for participation on advisory board from Alexion Pharma GK. Y. Ishikawa. and A. Shimono are employees of Alexion Pharma GK and shareholders of Alexion Pharmaceutical Inc. All other authors have nothing to disclose.
: Post-marketing surveillance was mandated by the Japanese government as part of the regulatory approval of eculizumab for aHUS in Japan. Post-marketing surveillance was conducted in accordance with Good Post-Marketing Study Practice (Ministry of Health, Labour and Welfare, Ministerial Ordinance No. 171 of 2004) to evaluate the safety and effectiveness of eculizumab in clinical practice. Ethical approval by an institutional review board is not mandatory for post-marketing surveillance.
: All procedures followed were in accordance with the Helsinki Declaration of 1964 and later versions. This article does not contain any studies with animal subjects performed by any of the authors.
: Informed consent from individual patients is not mandatory for post-marketing surveillance.