Two rectal artesunate suppository products for pre-referral management of severe malaria approved

If left untreated, uncomplicated malaria can progress within a few hours to severe malaria − a condition that can kill. In 2011, the World Health Organization (WHO) recommended that severe malaria be treated with injectable artesunate (Inj AS) in preference to quinine or artemether, as it saves more lives.1

As time is of the essence when treating severe malaria, the WHO also recommends the use of rectal artesunate (RAS) for prereferral management of the disease in areas where comprehensive treatment and care cannot immediately be provided. A single dose of RAS significantly reduces the risk of death and permanent disability. Specifically, RAS is recommended for “pre-referral treatment of severe malaria in children under 6 years of age in remote areas, so that cases of suspected malaria, for example, at community level can be treated without delay, pending immediate transfer to a higher-level facility where comprehensive care can be given.”2 As such, RAS buys time until Inj AS can be administered and can mean the difference between life and death.3 As soon as the child begins to recover and is able to take oral medication, they then receive a full course of artemisinin-based combination therapy (ACT).

Supported by Unitaid, MMV has been working with two Indian pharmaceutical companies, Cipla and Strides Shasun, to develop and obtain WHO prequalification for RAS products and thus create a sustainable supply. In 2016, the Expert Review Panel (ERP) of The Global Fund issued a 12-month authorization for procurement of Cipla’s product and then in 2017 for the Strides Shasun product, making RAS available to countries while awaiting prequalification. This allowed the first order of ~500,000 suppositories to be placed with Médecins Sans Frontières, President’s Malaria Initiative, The Global Fund and UNICEF.

In early 2018, the Cipla product received WHO prequalification – a landmark moment – making it the first RAS product to receive this international stamp of quality. In June 2018, Strides Shasun’s rectal artesunate product received WHO prequalification for their 100mg rectal artesunate suppositories.

MMV’s work in severe malaria has extended to support the manufacturers with the registration of RAS in several high-burden African countries.4 In parallel, in July 2017, MMV joined forces with international development organization Transaid, in collaboration with the National Malaria Elimination Centre (NMEC) of Zambia on a project known as MAMaZ5 Against Malaria (MAM) to improve severe malaria case management, in particular by introducing RAS at the community level. Implemented with several partners,6 the MAM project adopts innovative approaches, including the use of bicycle ambulances, as well as community theatre, song and dance to create awareness of malaria danger signs.

Updated July 2018

1. World Health Organization. Guidelines for the treatment of malaria. Third edition. April 2015.

2. World Health Organization Global Malaria Programme. Information Note: Rectal artesunate for pre-referral treatment of severe malaria (October 2017, rev. May 2018)

3. World Health Organization. Rectal artesunate testing and delivery (2016): 

4. RAS has been submitted for registration in Uganda and Nigeria and has been achieved in DRC.

5. MAMaZ: Mobilizing Access to Maternal Health Services in Zambia programme was led by Health Partners International (2010-2013, funded by DFID) and MORE MAMaZ, led by Transaid (2014-2016, funded by Comic Relief).

6. MAM partners: Transaid, Health Partners Zambia (HPZ), and the Zambian organizations Development Data and Disacare, together with MMV.