Target product profile for drugs to prevent pre-eclampsia

Overview

In women identified as being at increased risk of developing pre-eclampsia, prophylaxis with daily low-dose aspirin can reduce the risk of pre-eclampsia by 10–20%. For women living in areas with low calcium intake, high-dose calcium supplementation can reduce the risk of developing pre-eclampsia by more than 50%. However, pre-eclampsia remains a leading cause of maternal and newborn morbidity and mortality globally. There is an urgent need to identify new agents to prevent pre-eclampsia.

The World Health Organization (WHO) supports the development of missing health products that align with identified requirements and public health priorities. Recognizing that access, equity, and affordability are pivotal within the innovation process, WHO underscores their consideration across all stages of development, rather than solely post-production.

The purpose of this target product profile (TPP) is to provide guidance to product developers and funders about key characteristics and desired attributes of preventive agents that should be administered to pregnant women identified as being at increased risk of developing pre-eclampsia, accompanied by monitoring for the development of pre-eclampsia. This TPP outlines both minimal and preferred characteristics of a medicine that should:

• prevent the development of pre-eclampsia;
• have a good safety profile during pregnancy;
• be commenced early in pregnancy (before 20 weeks’ gestation) and continued throughout pregnancy and postpartum as required;
• be suitable for administration in any health care setting where pregnant women receive antenatal care, including in low- and middle-income countries.