Fosun Pharma’s medicine to protect pregnant women from malaria first to be approved by WHO

Quality-assured sulfadoxine-pyrimethamine now available

19 Nov 2018

MMV welcomes the WHO prequalification of sulfadoxine-pyrimethamine (SP) tablets from Guilin Pharma, a Fosun Pharma company. As the first quality-assured SP that is packaged and targeted for use in intermittent preventive treatment in pregnancy (IPTp), this new option will help improve access to a critical WHO-recommended intervention and protect more mothers-to-be from malaria in Africa.

An estimated 35 million women give birth annually in malaria-endemic areas of sub-Saharan Africa. Malaria in pregnancy is associated with an increased risk of adverse maternal and infant outcomes, with up to 200,000 new-born deaths each year because of malaria in pregnancy. To protect pregnant women and their unborn babies, the WHO recommends IPTp with SP to be administered at least three times to pregnant women from their second  trimester at a minimum of 1 month intervals. In 2016, an estimated 19% of eligible pregnant women received three or more doses of the intervention.

“MMV congratulates Fosun Pharma on achieving this important milestone,” said George Jagoe, EVP of Access & Product Management, MMV. “Malaria in pregnancy is a serious issue as two lives are at risk, not just one. We know that IPTp with SP can help reduce complications for mother and baby, yet coverage has been woefully low and access to quality-assured SP has been a challenge in most countries. The addition of a first-time WHO-prequalified SP to the global antimalarial medicine box is an important step in helping improve acceptability and quality of preventive antimalarials for pregnant women.”

Funded by Unitaid, MMV has been working with partners to improve coverage of SP for IPTp in Africa, as well as to improve global manufacturing solutions for quality SP, including the first-time prequalification of African manufacturers.