Two phase III and one phase II trials of concizumab in haemophilia A and B have been halted.- Novo Nordisk
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The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product NovoSeven (eptacog alfa activated), from Novo Nordisk. The CHMP adopted a new indication for the treatment of severe postpartum haemorrhage.
Positive data from two Phase III studies evaluating the efficacy and safety of ALN AT3 (fitusiran), from Sanofi, an investigational small interference RNA (siRNA) therapy for the prophylactic treatment of adults and adolescents with hemophilia A or B, with or without inhibitors, are presented at the 63rd American Society of Hematology (ASH) Annual Meeting.
Phase III studies of fitusiran were put on hold late 2020 because of side effect concerns including non-fatal thrombotic events, but the studies have now resumed, Sanofi highlighted in its 2020 financial results reporting on 5 February.