2 dossiers for rectal artesunate suppositories submitted for WHO prequalification

Severe malaria, a life threatening condition, may ensue rapidly if a bout of uncomplicated malaria is not promptly treated. Although the WHO Guidelines for the Treatment of Malaria include the use of rectal artesunate (RAS) for pre-referral intervention for severe malaria, there is currently no RAS product on the market approved either by WHO prequalification or by stringent regulatory authorities. This situation has hampered widespread availability and use of quality-assured RAS; it also forces malaria endemic countries to choose from sources of drug supply that fail to meet international standards.

MMV is working with two pharmaceutical partners (Strides and Cipla) to secure WHO prequalification of RAS as a deliverable of the UNITAID-funded project'Improving Severe Malaria Outcomes'. Beyond securing WHO prequalification, this work will support correct roll-out and use of RAS as a pre-referral intervention. Pre-referral intervention is one component of a properly integrated referral system; the goal of this referral mechanism is to ensure that after initial pre-treatment with RAS, severely ill patients are transported to health centres authorized to administer injectable artesunate or other WHO-recommended intravenous or intramuscular treatments for severe malaria, followed by a full course of oral ACT.