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Haemophilia . 2020 Jun 4.

Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: Results from the B-YOND extension study

Vittorio Branchi, Tobias J Weismüller, Taotao Zhou, Jonas Henn, Alexander Semaan, Tim R Glowka, Maria Gonzalez-Carmona, Christian Strassburg, Jörg C Kalff, Steffen Manekeller, Hanno Matthaei, Hiroki Kato, Hideo Nagatomo, Mitsuo Nakai, Tatsuhiro Sakaiya, Hidenori Terasaki, Tadashi Kondo, Yoichiro Hironaka, Katsuya Shimizu, Keisuke Shigemori, Nasim Shahidi Hamedani, Jens Müller, Fabian Tolle, Heiko Rühl, Behnaz Pezeshkpoor, Kerstin Liphardt, Johannes Oldenburg, Günter Mayer, Bernd Pötzsch, Evelyn Gaffal, Andrea M Kemter, Stefanie Scheu, Rafael Leite Dantas, Jens Vogt, Bernhard Baune, Thomas Tüting, Andreas Zimmer, Judith Alferink, Florian Langer, Stefan Kluge, Robert Klamroth, Johannes Oldenburg, Anne L Fletcher, Alfie T Baker, Veronika Lukacs-Kornek, Konstantin Knoblich, K John Pasi, Kathelijn Fischer, Margaret Ragni, Roshni Kulkarni, Margareth C Ozelo, Johnny Mahlangu, Amy Shapiro, Stephanie P'Ng, Hervé Chambost, Beatrice Nolan, Carolyn Bennett, Tadashi Matsushita, Bent Winding, Joachim Fruebis, Huixing Yuan, Dan Rudin, Johannes Oldenburg

Introduction: Recombinant factor IX Fc fusion protein (rFIXFc) has demonstrated efficacy for treatment of haemophilia B in the Phase 3 B-LONG and Kids B-LONG studies. However, long-term rFIXFc safety and efficacy data have not yet been reported.

PMID: 32497409