With MMV’s help, in November 2010, Guilin Pharmaceutical became the first company to receive WHO prequalification1 for their artesunate injection for the treatment of severe malaria.1 Since then, 75 million vials of injectable artesunate have been delivered to malaria-endemic countries. Given that injectable artesunate offers a 22% reduction in mortality compared to the alternative, quinine,2 an estimated 450,000 - 500,000 additional young lives have been saved by this medicine over this time period*.
Guilin Pharmaceutical has been manufacturing artesunate for injection since 1987. But without WHO prequalification or stringent regulatory approval, it could not be purchased by international organizations or with donor funds and was thus not reaching patients with severe malaria. When approached by Guilin, MMV decided to use its R&D know-how in a more unconventional way. Instead of developing a new product from scratch the team worked with Guilin to achieve WHO prequalification for the existing medicine.
At the same time the results of the landmark studies AQUAMAT and SEAQUAMAT were released, which demonstrated the superiority of injectable artesunate over intravenous quinine for the treatment of severe malaria in African and Asian patients respectively. The WHO then promptly updated their guidelines to strongly recommend artesunate injection as first-line treatment in preference to quinine for the treatment of severe P. falciparum malaria in adults and children.3
With the policy change in place, MMV and partners developed plans to increase its uptake and use across the malaria-endemic world. This involves advocacy work to ensure that evidence is disseminated far and wide as well as developing and testing training materials to ensure ease of use in African healthcare settings. As a result, the number of malaria-endemic countries updating their guidelines to include artesunate injection as an alternative to quinine continues to increase.
In December 2012, an MMV-led consortium was awarded a UNITAID grant of US$ 34 million to scale-up the use of injectable artesunate for severe malaria in disease-endemic countries. This 3-year project which ended in June 2016 was built around a consortium of implementing and procurement partners, with the participation of CHAI, Malaria Consortium, and Missionpharma. The beneficiary countries included: Cameroon, Ethiopia (SNNPR and OROMIA), Kenya, Malawi, Nigeria (13 states) and Uganda. During the project, almost 6.0 million vials of treatment have been introduced across the multi-country project, a sufficient quantity to treat between 1.0 million and 1.5 million children. In addition, more than 18,000 healthcare workers (at over 2,082 healthcare facilities) have been trained during the ISMO project regarding the correct preparation and administration of Inj AS.
Severe malaria is the condition that rapidly ensues if a bout of uncomplicated malaria is not promptly treated. Children are particularly vulnerable since they have little or no immunity with which to fend off the parasite. The symptoms can include coma, severe breathing difficulties, low blood sugar and severe anaemia, and if untreated, can lead to death.4
2. Dondorp AM et al. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet. 13;376(9753):1647-57 (2010).
* Updated November 2016