Severe malaria, a life-threatening condition, may ensue rapidly if a bout of uncomplicated malaria is not promptly treated. For severe malaria patients between 6 months and 6 years of age who are unable to immediately access WHO-recommended parenteral treatment (preferably injectable artesunate), pre-referral intervention with artesunate rectal capsules at the community level has been shown to save lives; in particular for critically ill young children unable to access parenteral treatment within 6 hours. Once admitted to a referral centre, patients should receive injectable artesunate, followed by a full treatment with an artemisinin-based combination therapy (ACT), as per WHO guidelines.
Although the WHO Guidelines for the treatment of malaria have included recommendations for the use of artesunate rectal capsules for over 10 years, the lack of quality-assured RAS product on the market hampered its widespread availability and use, forcing malaria-endemic countries to choose from sources of drug supply that did not meet international quality standards.
MMV collaborated with two pharmaceutical partners (Strides Pharma and Cipla) to develop and secure WHO prequalification of RAS as part of the Unitaid-funded project ‘Improving Severe Malaria Outcomes’ (ISMO).This work also supported the correct rollout and use of RAS as a pre-referral intervention.
In June 2017, after review of an application submitted by Cipla, the 100mg presentation of RAS was added to the WHO’s Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc). WHO’s Model EML identifies medicines that “satisfy the priority health care needs of the population.”
In 2018, both the Cipla and Strides Pharma RAS products secured WHO prequalification. It is estimated that over 80% of procured product is now WHO prequalified. In 2018,1.5 million orders of 100mg suppositories were placed by international donors to be delivered to malaria-endemic countries. Currently the product is registered in 16 countries.
As a pre-referral intervention, RAS is not intended to substitute for WHO-recommended parenteral treatments, preferably injectable artesunate. In addition, RAS is not intended as a substitute for the treatment of uncomplicated malaria, for which WHO recommends the use of artemisinin-combination therapies (ACTs).