The First Three Japanese Haemophilia A Patients in Whom Factor VIII Inhibitors Were Observed During Prophylactic Treatment With Efanesoctocog Alfa

Tazuko Tokugawa, MD, has received speaker fees from Sanofi K.K., Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd., Bayer Yakuhin Ltd., Pfizer Japan Inc., Fujimoto Pharmaceutical Corporation, Japan Blood Products Organization and CSL Behring K.K. Akihiro Sawada, MD, has received speaker fees from Sanofi K.K., Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd., Bayer Yakuhin Ltd., Pfizer Japan Inc., Fujimoto Pharmaceutical Corporation, KM Biologics Co. Ltd., Japan Blood Products Organization and CSL Behring K.K. Satoshi Higasa, MD, has received research funding from Chugai Pharmaceutical Co. Ltd. and received fees of speakers bureau from Sanofi K.K. Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd. Bayer Yakuhin Ltd., Pfizer Japan Inc. and CSL Behring K.K. Mariko Asai, MD, declare no conflicts of interest. Hideyuki Nakazawa, MD, receives a research support from Nobel Pharma and Nippon Kayaku, Honoria (fees for speaking and/or consultation) from Astellas Pharma Inc., AstraZeneca K.K., AbbVie GK, Asahi Kasei Pharma Corporation, Otsuka Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Gilead Sciences K.K., Sanofi K.K., Genmab K.K., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd., Novartis Pharma K.K., PharmaEssentia Japan K.K., Bristol-Myers Squibb K.K., Meiji Seika Pharma Co., Ltd., Janssen Pharmaceutical K.K., Swedish Orphan Biovitrum Japan K.K. and Takeda Pharmaceutical Company Limited. Azusa Nagao, MD, has received investigator-initiated research/education grant funding from Bayer Yakuhin Ltd., Pfizer Japan Inc. and Chugai Pharmaceutical Co., Ltd. A. Nagao is a medical advisor of Chugai Pharmaceutical Co., Ltd. and KM Biologics. and has received honoraria from Sanofi K.K., Takeda Pharmaceutical Pharmaceutical Company Limited, Chugai Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Fujimoto Pharmaceutical Corporation, KM Biologics, Pfizer Japan Inc., Novo Nordisk Pharma Ltd., Sysmex Corporation and CSL Behring K.K. Tomoko Yamaguchi, MD, received honoraria from Chugai Pharmaceutical Co. Ltd., Sanofi K.K., Bayer Yakuhin Ltd., Takeda Pharmaceutical Company Limited, Novo Nordisk, Pharma Ltd. Fujimoto Pharmaceutical Corporation and CSL Behring K.K. Yushi Chikasawa, MD, received fees of speakers bureau from Sanofi K.K., Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd., Bayer Yakuhin Ltd., Pfizer Japan Inc, Fujimoto Pharmaceutical Corporation, KM Biologics Co. Ltd., Japan Blood Products Organization, CSL Behring K.K. Masato Bingo, MD, has received research funding from Chugai Pharmaceutical Co., Ltd., and received fees of speakers bureau from Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., CSL Behring K.K., Fujimoto Pharmaceutical Corporation, Japan Blood Products Organization, KM Biologics Co., Ltd., Novo Nordisk Pharma Ltd., Pfizer Japan Inc., Sanofi K.K., Takeda Pharmaceutical Pharmaceutical Company Limited. Takeshi Hagiwara, MD, has received fees of speakers bureau from Sanofi K.K., Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Co. Ltd., Pfizer Japan Inc., KM Biologics Co. Ltd., Japan Blood Products Organization and CSL Behring K.K. Katsuyuki Fukutake, MD, has served on an advisor for CellGenTech Inc., and has acted as a consultant for Chugai Pharmaceutical Co. Ltd. and Sanofi K.K. and receives research funding from Novo Nordisk Pharma Ltd., Sanofi K.K. Chugai Pharmaceutical Co. Ltd. and Pfizer Japan Inc. and received fees of speakers bureau from Sanofi K.K., Takeda Pharmaceutical Company Limited, Chugai Pharmaceutical Co. Ltd., Novo Nordisk Pharma Ltd., Bayer Yakuhin Ltd., Pfizer Japan Inc., Sekisui Medical Co. Ltd., Fujimoto Pharmaceutical Corporation, KM Biologics Co. Ltd., Japan Blood Products Organization, CSL Behring K.K., Kyorin Pharmaceutical Co., Ltd. and Asahi Kasei Pharma Co. Limited information on these three cases is available exclusively in Japanese on the PMDA website, as a part of reports concerning suspected adverse reactions. The datasets generated during clinical observations of the patients with specific conditions are not publicly accessible due to ethical and privacy considerations. For inquiries regarding the data, please contact the corresponding author, who may be able to provide further information within the scope permitted by applicable regulations.