dm+d

Unassigned

Lactation Safety Information

Yes
-
Synonym: Recombinant coagulation factor VIII, porcine
No published evidence of safety
Unlikely to enter milk and not absorbed from the infant’s GI tract
Factor VIII is a normal component of maternal and infant plasma
20 October 2016

New Medicines

ObizurCongenital haemophilia A , with factor VIII inhibitors – in patients undergoing surgical or other invasive procedures

Information

Obizur
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Yes
Yes
May 21Removed from pipeline; development discontinued [5].
Feb 21PIII CHAWI study (NCT02895945) terminated as the benefit/risk profile did not support continuation in this patient population [4]

Category

First recombinant porcine factor VIII (FVIII).
It affects 1:4,000 to 1:5,000 live male births worldwide [1].
Congenital haemophilia A , with factor VIII inhibitors – in patients undergoing surgical or other invasive procedures
Intravenous infusion