title: Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency.
abstract: Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections.Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices.
authors: Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division eric.pelfrene@ema.europa.eu.
authors: Eric
authors: E
authors: Pelfrene
authors: Office of Regulatory Affairs, Human Medicines Research and Development Support Division; European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
authors: Marie-Hélène
authors: MH
authors: Pinheiro
authors: Office of Anti-infectives and Vaccines, Human Medicines Evaluation Division.
authors: Marco
authors: M
authors: Cavaleri
mesh_terms: D000962:Antimalarials / Q000627:therapeutic use*; D037621:Artemisinins / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004335:Drug and Narcotic Control; D005060:Europe; D006801:Humans; D008288:Malaria / Q000188:drug therapy / Q000469:parasitology; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D010963:Plasmodium falciparum
chemical_list: D000962:Antimalarials; D037621:Artemisinins; C031327:artemisinin
keywords: Artemisinin; Article 58; European Medicines Agency; Malaria; Orphan drug; Prequalification of Medicines Programme