GlaxoSmithKline Plc announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has approved a new drug, consisting of chlorproguanil hydrochloride and dapsone (Lapdap) for the treatment of Plasmodium falciparum (P.falciparum) malaria, the most life-threatening malaria parasite, which kills between 1-2 million people every year.

The combination of chlorproguanil hydrochloride and dapsone, for the treatment of uncomplicated P.falciparum malaria in adults and children over 5kg, has been developed specifically for use in sub-Saharan Africa where new interventions are urgently needed to address the risk of mortality and morbidity from P.falciparum.

Data from the Phase III clinical program conducted in sub-Saharan Africa demonstrated that, overall, chlorproguanil hydrochloride/dapsone achieved significantly higher cure rates compared to sulfadoxine-pyrimethamine (S/P) (96% vs. 89%; p<0.001) and was well tolerated. The most common adverse event associated with Lapdap was anemia, which only occurred in a small proportion of patients and was of limited duration.

Professor Peter Winstanley, (Director of the Wellcome Trust Tropical Center at The University of Liverpool), who has been closely involved in the development work, comments, "Drugs used as first-line treatment in uncomplicated P.falciparum malaria, such as S/P, are failing because of increasing parasite resistance. Chlorproguanil hydrochloride/dapsone can help us meet the urgent need for an affordable anti-malaria treatment for use in Africa, as it has been shown to work in cases where S/P has failed."

The new drug has a short half-life, which creates a short `resistance selection window' or exposure period to the parasite. This should help to preserve its antimalarial efficacy and make it a valuable addition to the armamentarium of anti-malarial drugs used in sub-Saharan Africa. GlaxoSmithKline (GSK) plans to make Lapdap available at preferential prices across sub-Saharan Africa as soon as local approval has been granted. The Certificate of Pharmaceutical Products (CPP) provided by the MHRA is required by most of the African regulatory authorities in their local approval process.

The malaria strategy recommended by WHO for Africa to further increase efficacy and reduce resistance, is to use anti-malarials in combination with artemisinin to form an Artemisinin Combination Therapy (ACT). The development of chlorproguanil hydrochloride/dapsone in a fixed dose artemisinin combination is underway.

Chlorproguanil hydrochloride/dapsone has been developed through a public/private collaboration between the WHO/TDR, (Tropical Disease Research Program of the World Health Organization), GSK, the UK Department for International Development (DFID), the University of Liverpool, the Liverpool School of Tropical Medicine, the London School of Hygiene and Tropical Medicine, and African researchers, with initial support by an early grant from the Wellcome Trust.

GSK will continue to work with the WHO, its other partners and local healthcare experts to ensure the appropriate use, safety and effectiveness of chlorproguanil hydrochloride/dapsone in the fight against P.falciparum malaria in sub-Saharan Africa.