MMV welcomes WHO approval of 3-year shelf-life for antimalarial ASMQ
The World Health Organization’s (WHO’s) Prequalification Team has announced a new extended shelf-life for the fixed-dose combination of artesunate+mefloquine (ASMQ) from 2 to 3 years. The longer shelf-life applies to the prequalification status of both presentations of ASMQ (25/50mg and 100/200mg) developed by Drugs for Negelected Diseases initiative and Farmanguinhos (Brazil) and manufactured by Cipla after a South–South technology transfer.
ASMQ is currently recommended as a first- or second-line treatment in five countries in South America and four countries in South-East Asia. The extended shelf-life will help reduce supply-chain management pressures related to warehousing and distribution of ASMQ in these countries. In 2007, WHO noted that all recommended artemisinin combination therapies (ACTs) had been approved with 2-year shelf-lives – making the supply management of ACTs ‘very difficult’. Since then, only one other ACT (artesunate+amodiaquine) has achieved a WHO-approved shelf-life of 3 years.
ASMQ is one of two antimalarial drugs developed by DNDi that were integrated into MMV’s portfolio in 2015. A once-a-day drug taken over 3 days, ASMQ is one of four fixed-dose ACTs recommended for the treatment of uncomplicated P. falciparum infections and for cure of blood stage infections caused by P. vivax, P. ovale, P. malariae or P. knowlesi in adults, children and infants over 5kg in areas with chloroquine-resistant infections.