Sulfadoxine-pyrimethamine

Product development

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Regulatory review

Swipha/Biogaran

Chemoprevention

Bioequivalence

Intermittent preventative treatment (TPP-1)

Product vision	Intermittent preventive treatment during pregnancy (IPTp) Intermittent preventive treatment of infants (IPTi)
Dosing	3 tablets of 500 mg sulfadoxine - 25 mg pyrimethamine (SP), to be given monthly at the beginning of the 2nd trimester of pregnancy until delivery
Efficacy	WHO affirmed the effectiveness of IPTp using SP (IPTp-SP), including in areas with SP resistance A full course of IPTp-SP estimated to decrease the incidence of low birthweight babies by 29%, severe maternal anaemia by 38%, and neonatal mortality by 31%.
Key features	One of the few health interventions showing reductions in neonatal mortality Adapted SP packaging to ensure correct use and to improve perception and uptake
Challenges	Delivery of IPTp requires a functioning antenatal care platform and access to quality-assured SP Improving quality perceptions about SP and expanding access through community health worker channels can increase IPTp coverage
Status	Bioequivalence study completed in 2020 Dossier submitted to WHO Prequalification
Next milestone	WHO prequalification Development of dispersible 250 mg sulphadoxine-12.5 mg pyrimethamine for intermittent preventive treatment for infants (IPTi)
Project Director	Pierre Hugo