Novo Nordisk has launched its coagulation factor IX (recombinant) glycoPEGylated drug Rebinyn in the US for the treatment of patients suffering from haemophilia B.
Known to affect around 5,000 of the population, haemophilia B is a serious, chronic, inherited bleeding disease characterised by low levels of clotting factor IX protein that leads to prolonged or spontaneous bleeding.
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Rebinyn has been formulated as an extended half-life injectable medicine that can be used to treat and control bleeding in both adults and children.
According to data from Phase III clinical trials, a single dose of 40IU/kg Rebinyn in adults demonstrated capability to increase factor activity above baseline levels by 94% and maintain average factor levels of 17% one week after dosing.
The drug was also investigated in the paradigm clinical trial programme, where it treated 98% of patient bleeds following administration of one or two doses.
In a separate surgical clinical study, one Rebinyn preoperative dose was found to be sufficient to successfully control bleeding during surgery.
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By GlobalDataNovo Nordisk Biopharmaceuticals corporate vice-president Pia D’ Urbano said: “The introduction of Rebinyn energises us to build on our rich legacy of making innovative medicines available for people with rare bleeding disorders.”
Earlier this month, the firm also released two new injections, Ozempic (semaglutide) and Fiasp (insulin aspart) for diabetes patients in the US.
All three of Novo Nordisk’s newly launched medications were approved by the US Food and Drug Administration (FDA) last year.
