Children are at most risk of dying from malaria. This is why MMV is committed to developing and facilitating access to antimalarial medicines specifically for young populations.
The COVID-19 pandemic has threatened gains made against malaria in children. MMV is working hard to ensure that antimalarial medicines appropriate for children remain available, while bringing forward new formulations.
Medicines are absorbed and metabolized differently in children and should be adapted for their weight and age. To date, MMV and partners have developed and brought to market nine child-friendly formulations (below). In addition, MMV is working with other organizations as part of the PAMAfrica consortium to develop the first malaria treatment for children under 5kg.
The COVID-19 pandemic is an additional complication to the development of new antimalarial medicines and the accessibility of existing ones, bringing new challenges to malaria prevention and control. But malaria stops for no pandemic and while children are at risk our work will continue. Here are the medicines MMV and partners have brought forward to treat and prevent malaria in children:
SPAQ for Seasonal Malaria Chemoprevention (SMC)
MMV has worked with Fosun Pharma and S Kant to bring forward two sulfadoxine-pyrimethamine + amodiaquine products for seasonal malaria chemoprevention in children. 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. This dramatic scale-up has been achieved in part by the distribution of 96 million treatment courses of SPAQ (Fosun Pharma and S Kant products combined) in 13 countries in 2019, bringing the total number of courses distributed since 2014 to 357 million.
The first product successfully co-developed by MMV and partners was Coartem® Dispersible (artemether-lumefantrine), launched by Novartis in 2009. To date, 400 million treatments of this cherry-flavoured dispersible product have been distributed, making it the most widely distributed quality ACT for children.
Artesunate for Injection
Artesun®, developed by Fosun Pharma, was the first injectable artesunate product to receive WHO prequalification (PQ) with the support of MMV. Since its approval in 2010, the use of Artesun has been widespread, having been approved in 33 malaria-endemic countries. In December 2018, Ipca Laboratories achieved WHO-PQ for its product, Larinate® 60 mg. With MMV’s support, Larinate 60 has now been registered and launched in 12 countries. As a result, a total of 168 million vials of injectable artesunate have been distributed to date, estimated to have saved the lives of more than one million additional children compared with quinine (assuming that patients would have received injectable quinine in the absence of injectable artesunate).
Artesunate rectal capsules (ARC)
This prereferral treatment is used to gain time before transfer to an appropriate health facility. Supported by grants from Unitaid, MMV has worked with industry partners since 2013 to bring 100 mg artesunate rectal capsules to market. Both manufacturers’ products achieved WHO-PQ in 2018, enabling countries to procure these life-saving products – ArtecapTM (Strides Pharma Science Ltd) and Artesunate Rectocaps (Cipla Ltd) – using donor funds. These products are currently registered in 16 countries in sub-Saharan Africa, and a total of 3.2 million capsules have been delivered to date.
Later in 2015, Pyramax® granules (pyronaridine-artesunate), developed by Shin Poong Pharmaceutical and MMV, received a positive scientific opinion under Article 58 from the European Medicines Agency (EMA), becoming the second ACT specifically designed for paediatric use to receive approval from a stringent regulatory authority.
A third ACT co-developed by MMV (with Sigma-Tau), Eurartesim® (dihydroartemisinin-piperaquine), was approved by the EMA in 2011 and received WHO prequalification in 2015. The paediatric formulation has completed clinical development and will be submitted for EMA approval.
Moving forward, MMV is developing next-generation medicines with paediatric formulations in parallel with adult formulations, thereby accelerating access to the main target population: children under the age of 5.