Ganaplacide plus lumefantrine solid dispersion formulation: considerations for development and rollout

Due to reliance on antimalarials for clinical case management, drug resistance is a recurrent challenge for malaria control and elimination that requires relentless discovery and development of novel medicines with new modes of action.1 Since the widespread use of chloroquine in the 1950s, resistance has compromised the efficacy of all major classes of antimalarial drugs that are widely used to treat Plasmodium falciparum. A phase 2 safety and efficacy study in children aged 6 months and older is underway (NCT04546633), and a phase 3 trial will commence this year.7 Regulatory discussions have been initiated with various agencies, including the US Food and Drug Administration and Marketing Authorisation for Global Health Products in Switzerland, which involves WHO and regulators from disease endemic countries (Wells T, Medicines for Malaria Venture, personal communication). For regulatory approvals, WHO prequalification will be essential to enable drug availability in endemic countries using major funders, including UNITAID and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.9 For manufacturing, ample production with backup facilities in case of supply chain disruptions and drug stock-outs will be necessary.