The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an extension of the Novo Nordisk’s NovoSeven (eptacog alfa) label to include treatment of women suffering from severe haemorrhage after giving birth, when medications used to induce uterine contractions and reduce bleeding (uterotonics) are insufficient to stop the bleeding.
Severe postpartum haemorrhage (PPH) is when a woman suffers from blood loss of more than 1,500 mL within 24 hours after giving birth. It accounts for 1 in 4 maternal deaths globally, making it a significant contributor to maternal morbidity, the company explained.
The positive opinion is based on data from a prospective randomised clinical trial in women with severe PPH where uterotonics had failed to control the bleeding. In the primary analysis, fewer women in the NovoSeven arm (21 vs 35) underwent additional medical procedures, such as ligation and embolisation, to stop the bleeding, corresponding to a 40% relative reduction in risk compared to standard of care.
“Postpartum haemorrhage is a serious and dangerous condition,” said Martin Lange, executive vice president and head of Development at Novo Nordisk. “Reducing maternal mortality is a United Nations Sustainable Development Target and something that is very important to us at Novo Nordisk. We’re pleased with the potential of NovoSeven being able to help mothers who may need it.”
Novo Nordisk said that it expects a final approval by the European Commission within approximately two months.