EMA recommend new treatment option for severe postpartum haemorrhage

pharmafile | April 25, 2022 | News story | Sales and Marketing  

Novo Nordisk has announced that the EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on NovoSeven® (eptacog alfa). The committee has recommended an extension of the NovoSeven label to include treatment of people suffering from severe haemorrhage after giving birth.

The recommendation is for severe haemorrhage following childbirth, when medications used to induce uterine contractions and reduce bleeding (uterotonics) are insufficient to stop the bleeding. Severe postpartum haemorrhage (PPH) is defined as when a woman suffers from blood loss of more than 1,500 mL within 24 hours after giving birth, regardless of the route of delivery (vaginal or caesarean). 1,500 mL of blood accounts for approximately 25% of the person’s total blood volume.

“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.”

PPH accounts for one in four maternal deaths globally, making it a significant contributor to maternal morbidity, and is the most common form of major childbirth-related haemorrhage.

The positive opinion is based on data from a prospective randomised clinical trial in those with severe PPH where uterotonics had failed to control the bleeding. In the primary analysis, fewer patients in the NovoSeven® arm (21 vs 35) underwent additional medical procedures, such as ligation and embolisation, to stop the bleeding. The contrasts to a 40% relative reduction in risk compared to standard of care. 

Novo Nordisk has shared that the company expects a final approval by the European Commission within approximately two months.

Ana Ovey

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