Antimalarial medicines and molecules geared towards the needs of children
A child dies from malaria every 2 minutes – the vast majority from Africa. To help reduce this burden, MMV has built the richest malaria drug pipeline in history, with 13 new antimalarials now treating patients. These medicines have contributed to saving more than 2.2 million lives and are helping bend the curve towards the eradication of malaria. To mark World Children’s Day 2020, we are proud to present the antimalarials MMV and partners have developed for children, as well as the projects we are working on for the future.
MMV’s first co-developed medicine, Coartem® Dispersible (artemether-lumefantrine), was a child-friendly formulation developed with Novartis and launched in 2009. Over 390 million treatments have been distributed, making it one of the most widely used quality ACTs for children. It is estimated to have saved 840,000 young lives and counting…
In 2010, with MMV’s help, Guilin Pharmaceutical became the first company to receive WHO prequalification for their injectable artesunate, Artesun® for the treatment of severe malaria. Since then, to diversify the supply, MMV has worked with Ipca Laboratories to achieve prequalification for its product Larinate® 60mg. As a result, 168 million vials of injectable artesunate have been distributed to date, estimated to have saved over one million additional young lives compared to treatment with quinine.
Artesunate rectal capsules (ARC), for pre-referral management of severe malaria, can be given to critically ill children who are unable to take oral medicines. Untreated severe malaria can be fatal. Studies show that for children living 6 or more hours from a health centre where they could receive recommended treatment, ARC can reduce death and disability significantly. MMV collaborated with two pharmaceutical partners (Strides Pharma and Cipla) to develop and secure WHO prequalification of ARC as part of the Unitaid-funded project ‘Improving Severe Malaria Outcomes’ (ISMO). As of the end of 2019, 3.2 million ARC have been distributed, resulting in an estimated 400,000 lives saved.
In 2015, Pyramax® granules (pyronaridine-artesunate), developed with Shin Poong Pharmaceutical, received a positive scientific opinion under Article 58 from the European Medicines Agency. It became the second quality child-friendly ACT available to malaria-endemic countries and over 400,000 children were treated with Pyramax® in 2019.
In 2018, tafenoquine (TQ; Kozenis/Krintafel),1 developed in partnership with GSK became the first new treatment for the prevention of relapse of P. vivax malaria in more than 60 years – and the first-ever single-dose treatment for this indication. To expand access to TQ for one of the most at-risk patient populations (children under 16), a paediatric formulation has been developed through the TEACH2 study. The results of this study will support a regulatory submission before the end of 2020.
Ganaplacide/lumefantrine is a novel combination currently being assessed for its potential use in acute, uncomplicated malaria through an MMV and Novartis partnership. It entered Phase IIb clinical studies in 2017 in nine countries across Africa and Asia. Results from part A of the study, in adults and adolescents aged ≥12 years, showed rapid killing of parasites and a low rate of treatment failure. In part B of the study, the combination will be tested in children aged 2–12 years.
Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) has been shown in clinical trials to reduce cases of malaria by 75% in children under 5,3 while post-implementation data from Mali and Burkina Faso have shown it reduces malaria by 44–62%.4,5 MMV has supported manufacturers Fosun Pharma and S Kant to secure WHO prequalification for their SPAQ products. Since the launch of SMC in 2014, the number of protected children has increased from 3 million in 2015 to over 20 million in 2019.
Owing to the life-saving impact of SMC, MMV’s SEAMACE6 programme will explore ways to expand coverage of SMC in the coming years; this may include extending the target age range, expanding geographic coverage within the Sahel, and increasing the duration of coverage where warranted (from 3–4 to 3–5 months). Given the threat of sulfadoxine-pyrimethamine resistance in eastern and southern Africa, MMV and partners are exploring alternative or new combination therapies that could offer chemoprevention to children in that region.
Slide 1: Novartis; Slide 2: Anna Wang; Slide 3: Anna Wang; Slide 4: Maud Majeres Lugand/MMV; Slide 5: Maud Majeres Lugand/MMV; Slide 6: Anna Wang; Slide 7: Alena Koscalove/MSF; Slide 8: Amevi Wisdom/Unsplash
1.Tafenoquine is marketed as Kozenisin Australia and Krintafel in the USA. Trademarks are owned or licensed to the GSK group of companies.
2. Tafenoquine Exposure Assessment in Children.
3. World Health Organization. Seasonal malaria chemoprevention (Last updated: 1 May 2017): http://www.who.int/malaria/areas/preventive_therapies/children/en/index.html
4. Druetz T. “Evaluation of direct and indirect effects of seasonal malaria chemoprevention in Mali". Sci Rep 8, 8104 (2018).
5. Druetz T et al. “Impact Evaluation of Seasonal Malaria Chemoprevention Under Routine Program Implementation: A Quasi-Experimental Study in Burkina Faso.” Am J Trop Med Hyg. 98 (2): 524-533 (2018).
6. SEAsonal MAlaria Chemoprevention Extension.