A significant barrier to improving global maternal and perinatal health is under-investment in pharmaceutical research and development (R&D) of medicines for pregnancy-specific conditions. Target product profiles (TPPs) are a well-recognised strategy to promote development of innovative medical products, such as devices, diagnostic tests and therapeutics.
The World Health Organization (WHO) defines a TPP as a document that describes the minimum and preferred (or optimal) characteristics of a target product, aimed at a particular disease or diseases. They specify the key characteristics that the intervention must address, such as (but not limited to) clinical indication, target population, desired efficacy, safety, formulation/presentation and stability and storage. TPPs are an important resource for multiple stakeholders in the R&D pathway, including funders, researchers, product developers, manufacturers and regulators.
The two TPPs discussed in this survey have been formulated to meet the need for novel medicines for the prevention and management of preterm birth. Spontaneous preterm labour accounts for up to 50% of preterm births. Preterm birth is the leading cause of neonatal mortality, accounting for 35% of neonatal deaths globally. Preterm newborns that survive are at an increased risk of a number of short- and long-term adverse health outcomes, including chronic lung disease, and neurological, visual and auditory disabilities.
There are currently very few effective medicines for preventing preterm birth in women at risk. Some tocolytic agents are available that can prolong pregnancy for 2 to 7 days in women experiencing spontaneous preterm labour, however there is a lack of evidence that current treatments improve substantive fetal and neonatal health outcomes. There is an urgent need for new tocolytics that can prolong pregnancy and reduce the adverse perinatal outcomes associated with preterm birth.
Your views on medicines for preterm birth.
This page contains draft documents of two TPPs for
1) the prevention of preterm birth and
2) the treatment of preterm labour for public consultation.
If you wish to submit a response, please email [email protected]
For your information, all the comments you provide will be treated as non-identifiable, which means that we will not attribute these comments to you by name, nor will anything that could identify you be released outside of our study team.