In what ways might the first approved treatment for preeclampsia transform global maternal‑health equity and reshape pharmaceutical market incentives?
The approval of a first-in-class pharmaceutical treatment for preeclampsia would represent a watershed moment in maternal-fetal medicine, addressing one of the most significant unmet needs in global obstetric care while simultaneously catalyzing transformative shifts in how the pharmaceutical industry approaches women's health therapeutics.
Preeclampsia and related hypertensive disorders of pregnancy constitute a leading cause of maternal and neonatal mortality worldwide, imposing substantial burdens on families, communities, and healthcare systemsEconomic evaluation of Community Level Interventions for Pre ...nih . The condition affects 5-8% of all births in the United States, with incidence rates ranging from 2-5% in developed nationsPreeclampsia And Maternal Mortality: A Global Burdenpreeclampsia . However, the disease burden falls disproportionately on women in resource-limited settings—a woman in a developing country is seven times more likely to develop preeclampsia than her counterpart in a developed nation, and 10-25% of these cases result in maternal deathPreeclampsia And Maternal Mortality: A Global Burdenpreeclampsia .
The geographic concentration of mortality is stark: nearly all preeclampsia-related deaths (greater than 99%) occur in low-and-middle-income countries, particularly in South Asia and Sub-Saharan AfricaEconomic evaluation of Community Level Interventions for Pre ...nih . In Latin America, preeclampsia ranks as the leading cause of maternal deathPreeclampsia And Maternal Mortality: A Global Burdenpreeclampsia . Severe forms of the disease, including eclampsia, are more prevalent in developing regions, ranging from 4% to 18% of deliveries in parts of AfricaPreeclampsia And Maternal Mortality: A Global Burdenpreeclampsia .
Preeclampsia represents the first or second leading cause in the ranking of avoidable causes of maternal death, with approximately 16% of all maternal deaths attributable to eclampsia and preeclampsiaPre-eclampsia in low and middle-income settings: What are the barriers to improving perinatal outcomes and evidence-based recommendations? - PubMednih . A 20-fold increase in maternal mortality is associated with preeclampsia arising at less than 32 weeks compared with that at 37 weeks or greaterScholarly articles for maternal mortality preeclampsia comparison low middle income high incomegoogle .
The World Health Organization maintains a comprehensive list of maternal health commodities for preeclampsia management, which includes calcium supplementation for prevention in women with low dietary calcium intake, aspirin for prevention in high-risk women, and magnesium sulfate for eclampsia prevention and treatment[PDF] List of key WHO-recommended maternal and newborn health ... - IRISwho +1. Antihypertensive agents such as labetalol, methyldopa, nifedipine, and hydralazine address hypertension management[PDF] List of key WHO-recommended maternal and newborn health ... - IRISwho .
However, these interventions are fundamentally preventive or symptomatic—no approved pharmaceutical treatment exists that addresses the underlying pathophysiology of established preeclampsia. The economic analysis of magnesium sulfate illustrates this limitation: while it costs only $456 to prevent one case of eclampsia in low gross national income countries (compared to $21,202 in high GNI countries), this represents prevention of seizure complications rather than treatment of the underlying diseaseCost-effectiveness of prophylactic magnesium sulphate for 9996 ...nih .
Two distinct molecular approaches are advancing through clinical development with the potential to become the first approved preeclampsia treatments:
DM199 represents a recombinant form of human tissue kallikrein-1, a serine protease enzyme that plays an important role in regulating diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factorDiaMedica Therapeutics Provides DM199 Preeclampsia Program Update Following Pre-IND Meeting with FDA :: DiaMedica Therapeutics, Inc. (DMAC)diamedica . The drug stabilizes the lining of blood vessels, making them "happier" while improving blood flow to the womb at a critical time when the baby needs itPromising new drug for preeclampsia, a pregnancy complication : NPRnpr .
The ongoing Phase 2 investigator-sponsored trial in South Africa has dosed over 30 women with late-stage preeclampsia, with interim data showing encouraging safety and efficacy signals, including statistically significant reductions in blood pressure and dilation of intrauterine arteriesDiaMedica Therapeutics Provides DM199 Preeclampsia Program Update Following Pre-IND Meeting with FDA :: DiaMedica Therapeutics, Inc. (DMAC)diamedica . Critically, the drug shows no placental transfer, thereby minimizing unforeseen fetal exposureDiaMedica Therapeutics Provides DM199 Preeclampsia Program Update Following Pre-IND Meeting with FDA :: DiaMedica Therapeutics, Inc. (DMAC)diamedica . Tests indicate the drug doesn't appear to cross into the placenta or breastmilk, suggesting it likely doesn't reach the babyPromising new drug for preeclampsia, a pregnancy complication : NPRnpr .
CBP-4888 is a fixed-dose combination of two chemically-synthesized, lipid-conjugated small interfering ribonucleic acid duplex oligonucleotides designed to decrease the production of soluble fms-like tyrosine kinase-1 mRNA isoforms in the placentaPre-Eclampsia Pipeline Drugs, Insights, Companies, MOA - DelveInsightdelveinsight . The drug has received FDA Fast Track designation for the treatment of sFlt1-mediated pre-term preeclampsiaComanche Biopharma Receives US FDA Fast Track Designation for CBP-4888 for the Treatment of sFlt-1 mediated pre-term preeclampsia – Comanche Biopharmacomanchebiopharma and European Medicines Agency orphan drug designationComanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in sFlt1-mediated Preterm Preeclampsia – Comanche Biopharmacomanchebiopharma .
Although preeclampsia affects 3-8% of pregnancies, when considered against the total population, the incidence approximates 3.8 per 10,000 individuals—comfortably meeting the threshold for rare disease classificationPreeclampsia – Will Orphan Drug Status Facilitate Innovative ... - PMCnih . This strategic framing has enabled companies to secure orphan drug designation, which provides seven-year market exclusivity, tax credits for qualified clinical trials, waiver of marketing application user fees, and potential for orphan drug grantsDesignating an Orphan Product: Drugs and Biological Products | FDAfda +1.
The EMA grants orphan drug designation to products intended for life-threatening or chronically debilitating diseases affecting fewer than five in 10,000 people in the European Union, providing protocol assistance, market exclusivity, and regulatory fee reductionsComanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in sFlt1-mediated Preterm Preeclampsia – Comanche Biopharmacomanchebiopharma . Preeclampsia is estimated to impact approximately four in 10,000 pregnancies in the EU each year, qualifying under this thresholdComanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in sFlt1-mediated Preterm Preeclampsia - BioSpacebiospace .
The global preeclampsia treatment market was valued at approximately $1.2 billion in 2024 and is projected to reach $2.5 billion by 2033, growing at a compound annual growth rate of 9.5%Pre Eclampsia Treatment Market Industry Analytics and Forecast ...linkedin . The healthcare burden from pregnancy-related conditions, specifically preeclampsia, carries an estimated global healthcare cost of $3 billionPreeclampsia – Will Orphan Drug Status Facilitate Innovative ... - PMCnih .
This market trajectory represents a significant commercial opportunity that could attract sustained pharmaceutical investment. The demonstration that pregnancy-focused therapeutics can achieve blockbuster potential would fundamentally alter industry risk calculus regarding maternal-fetal medicine investment.
The pharmaceutical industry has historically viewed pregnancy drug development as prohibitively risky, with thalidomide casting a very long shadow over the fieldPregnancy and Pharmaceuticals Bridging the Innovation Gapyoutube . Global R&D funding for pregnancy-associated complications has been grossly underfunded, with less than 1% of health research budgets in the US or UK allocated to reproductive healthPreeclampsia – Will Orphan Drug Status Facilitate Innovative ... - PMCnih .
A successful preeclampsia approval would demonstrate that:
The FDA's Pregnancy and Lactation Labeling Rule (PLLR), effective since 2015, requires updated product labeling with relevant information for pregnant and lactating populations, and mandates pregnancy exposure registries with contact informationMedication safety in pregnancyyoutube . The PRGLAC Task Force, established in 2018, provides guidance specifically for pregnant and lactating individualsMedication safety in pregnancyyoutube . These regulatory frameworks create a more navigable pathway for obstetric drug development.
The WHO prequalification program provides a validated mechanism for ensuring quality maternal health medicines reach procurement channels. Established in 2001, the program maintains a list of products meeting WHO-recommended standards of quality, efficacy, and safetyPutting the “Quality” into Maternal Health Medicinesyoutube . The collaborative procedure enables national medicines regulatory authorities to achieve faster registration of prequalified products, with participating countries committing to decision timelines of 90 daysThe WHO PQ Collaborative Procedure for Accelerated Registrationyoutube .
For maternal health commodities specifically, misoprostol and magnesium sulfate were added to the prequalification program in 2006 alongside other reproductive health medicinesPutting the “Quality” into Maternal Health Medicinesyoutube . The full prequalification process typically requires 18-20 months on averagePutting the “Quality” into Maternal Health Medicinesyoutube . A novel preeclampsia treatment could follow this established pathway to reach UN procurement agencies.
The Medicines Patent Pool has explicitly expanded its mandate to include maternal health, with the stated goal of establishing voluntary licensing as an effective access mechanism for non-communicable disease and maternal health in low-and-middle-income countriesMedicines Patent Pool (MPP) strategy for 2023-2025. Innovative public health at its best!youtube . The organization's approach facilitates access to existing treatments while supporting development of new formulations and health technologies, including medicines for maternal healthGreater Access to Medicines & Health Technologies | Brochuremedicinespatentpool .
The voluntary licensing mechanism has demonstrated substantial impact: since 2012, MPP has facilitated supply of 43.56 billion doses, generated $1.9 billion in savings (with $3.9 billion projected by 2030), and engaged 56 generic partners across 14 countries through agreements with 22 patent holdersGreater Access to Medicines & Health Technologies | Brochuremedicinespatentpool . Through this approach, MPP has shortened the time required to deliver essential drugs to people in low-and-middle-income countriesAccess to medicines during the COVID-19 pandemic. The role of The Medicines Patent Poolyoutube .
The precedent established by Merck's molnupiravir licensing strategy—combining tiered pricing based on World Bank country income criteria, voluntary licenses to generic manufacturers, and licensing agreements with the Medicines Patent Pool covering more than 100 low-and-middle-income countries—provides a template for preeclampsia treatment accessMerck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, Receives Special Approval for Emergency in Japanbusinesswire .
Pharmaceutical companies have established tiered pricing approaches for global health products, where low- and lower-middle-income countries pay not-for-profit prices while upper-middle-income countries pay according to defined pricing tiersPFIZER REPORTS STRONG THIRD-QUARTER 2022 RESULTS AND RAISES 2022 OUTLOOKbusinesswire . Merck has implemented tiered pricing based on World Bank country income criteria to reflect countries' relative ability to finance health responsesMerck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, Receives Special Approval for Emergency in Japanbusinesswire .
The equity impact of any approved treatment depends critically on diagnostic capabilities. The sFlt-1/PlGF ratio test, while highly effective for ruling in and ruling out preeclampsia, faces implementation barriers in low-resource settings. Testing costs approximately 70 USD in some settings (55-60 USD equivalent), and laboratory-grade systems may not be applicable to LMIC settings where point-of-care systems would be more appropriateZSOG Annual conference Session 2: Pre-eclampsia screening in developing countriesyoutube +1.
In Malaysia, serum sFlt-1/PlGF ratio testing has been suggested by clinical practice guidelines but is not widely implemented, especially in government health clinics settingsThe feasibility of soluble Fms-Like Tyrosine kinase-1 (sFLT-1) and Placental Growth Factor (PlGF) ratio biomarker in predicting preeclampsia and adverse pregnancy outcomes among medium to high risk mothers in Kuala Lumpur, Malaysiaplos +2. Establishing threshold values that account for local situations is necessary for issuing clinical recommendations in different LMIC contextsProspective Study Evaluating the Association Between sFlt-1/PlGF ...jogc .
The potential value of biomarker testing in low-resource settings is substantial: using the sFlt-1/PlGF ratio alongside blood pressure measurement (rather than a full laboratory panel) could optimize use of limited resources and cost-effectively eliminate repeated clinical laboratory testing among patients with normal initial results sFlt1/PlGF among patients with suspected preeclampsia when considering hypertensive status - PMC nih .
Even with approved treatments and diagnostic capabilities, equity impact depends on whether pregnant women access healthcare systems early enough to receive screening and treatment. In Western and Central Africa, only 57% of pregnant women received four or more antenatal care visits in 2023Antenatal care - UNICEF DATAunicef . In South Asia, only 58% achieved this thresholdAntenatal care - UNICEF DATAunicef .
Sub-Saharan Africa and South Asia, which account for 99% of the world's maternal deaths, record the lowest ANC attendance rates globally—52% in sub-Saharan Africa and 46% in South AsiaDeterminants of antenatal care dropout among pregnant women in ...springer . Only 30% of women in some high-burden settings book for antenatal care before 16 weeksZSOG Annual conference Session 2: Pre-eclampsia screening in developing countriesyoutube .
There are significant socio-economic gaps in ANC utilization: concentration index analysis reveals positive and statistically significant wealth-related (CIX = 0.30) and education-based inequalities (CIX = 0.33) in achieving eight or more ANC visitsUtilisation of eight or more antenatal care visits and its associated socio-economic-related inequalities in sub-Saharan Africa: A decomposition analysis | PLOS Oneplos . Only 8.9% of women in SSA achieve eight or more ANC visitsUtilisation of eight or more antenatal care visits and its associated socio-economic-related inequalities in sub-Saharan Africa: A decomposition analysis | PLOS Oneplos .
Late antenatal care booking has been identified as the main reason for discontinuation of maternal health services, with women's negative experiences including poor quality of care, incompetent and unfriendly providers, disrespectful care, high opportunity costs, and difficulties obtaining transportationCommunity’s experience and perceptions of maternal health services across the continuum of care in Ethiopia: A qualitative studyplos .
Cold chain limitations pose significant challenges for pharmaceutical distribution in high-burden regions. On average, Africa wastes approximately 50% of its food due to inefficient supply chain infrastructure, and cold storages for pharmaceutical products often lack capacity to store medicines according to WHO guidelinesPotentials and Challenges of Cold Chain in Africa - Alg Globalalg-global . Reliability of electricity supply is a persistent problem due to power outages and voltage fluctuationKnowledge, perception and practice towards oxytocin stability and quality: A qualitative study of stakeholders in three resource-limited countriesplos .
However, DM199 being a protein therapeutic administered subcutaneously offers potential advantages—similar protein therapeutics can be transported without extensive cold chain requirements if properly formulated. Maternal nutrition products, for comparison, generally do not require cold chain, though moisture, light, and temperature stability are critical considerationsMaternal Nutrition Market Size to Surpass USD 70.36 Billion by 2035, Driven by Preventive Healthcare and AI-Led Innovationglobenewswire .
Health technology assessment bodies in different jurisdictions apply varying willingness-to-pay thresholds. In European high-income settings, cost-effectiveness analyses have used thresholds of €50,000 to €100,000 per preeclampsia case avertedEarly cost-effectiveness analysis of screening for preeclampsia in nulliparous women: A modelling approach in European high-income settingsplos . For LMICs, willingness-to-pay thresholds based on GDP per capita are substantially lower: one to three times GDP per capita yields thresholds of $429-$1,287 for Mozambique, $1,368-$4,105 for Pakistan, and $1,729-$5,188 for IndiaEconomic and cost-effectiveness analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials in India, Pakistan and Mozambique | BMJ Global Healthbmj .
A diagnostic device analysis found that the most cost-effective combination for preeclampsia detection yielded an incremental cost-effectiveness ratio of $93.6 per DALY gained relative to no access to diagnostic devicesCost effectiveness of medical devices to diagnose pre-eclampsia in low-resource settings - ScienceDirectsciencedirect . When access to treatment is limited, it is more cost-effective to improve access to treatment than to increase testing rates or diagnostic device sensitivityCost effectiveness of medical devices to diagnose pre-eclampsia in low-resource settings - ScienceDirectsciencedirect .
Historical precedent demonstrates that first-in-class approvals catalyze subsequent investment. The approval of mRNA vaccines for COVID-19 approximately 11 months after publication of the viral sequence highlighted the transformative potential of nucleic acid technology and prompted extensive investment in the platformThe clinical progress of mRNA vaccines and immunotherapiesnature . The market now features more than 70 potential KRAS inhibitors in active development following Amgen's first KRAS inhibitor approvalNavigating the Landscape: 30th Annual Pharma R&D Review 2022 Webinaryoutube .
Recent acquisitions signal growing interest in maternal health: Bayer AG acquired KaNDy Therapeutics in 2020 to expand its women's healthcare pipeline; Merck acquired Alydia Health in 2021 to address postpartum hemorrhage; and Johnson & Johnson launched the Maternal-fetal Immune Disorders QuickFire Challenge focused on health equity in 2022Maternal Health Therapeutics Market Size, Share | Growth [2034] fortunebusinessinsights .
Current clinical trials examining repurposed drugs (statins, metformin) for preeclampsia, alongside novel approaches like DM199 affecting the bradykinin pathway and CBP-4888 targeting soluble Flt-1, indicate that this is "a really exciting field" with significant UK leadership and opportunityPregnancy and Pharmaceuticals Bridging the Innovation Gapyoutube .
The UK offers particular advantages for pregnancy drug development: the NHS enables lifetime follow-up of fetuses exposed in utero, potentially at low costPregnancy and Pharmaceuticals Bridging the Innovation Gapyoutube . A pilot launching in March 2025 will ask sponsors to create inclusion plans for pregnant populations early in developmentPregnancy and Pharmaceuticals Bridging the Innovation Gapyoutube .
Extending patent exclusivity periods for obstetric drugs—analogous to pediatric exclusivity provisions—has been proposed to help companies recoup investment given the relatively short treatment duration compared to chronic disease medicationsPregnancy and Pharmaceuticals Bridging the Innovation Gapyoutube .
The approval of a first-in-class preeclampsia treatment would generate transformative effects across multiple dimensions:
For Global Health Equity:
For Pharmaceutical Market Incentives:
For Healthcare Systems:
The magnitude of impact will ultimately depend on implementation factors including diagnostic accessibility, antenatal care coverage, cold chain requirements, pricing strategies, and voluntary licensing arrangements. However, the approval itself would represent a paradigm shift—demonstrating that the therapeutic orphaning of pregnancy-related conditions is neither scientifically necessary nor commercially inevitable.