The European Union (EU) Commission has awarded approval to Amivas Ireland to commercialise its flagship malaria product Artesunate Amivas in the EU and European Economic Area (EEA).
The approval was based on the recent recommendation by the Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for the medicinal product. Artesunate has had an orphan designation by the European Medicines Agency (EMA) since 2007 but had no marketing authorisation on the continent.
Treatment of malaria in tourists and military personnel enabled
The decision enables Amivas to increase production and establishes channels to meet the treatment needs of the approximately 1,250 individuals diagnosed with severe malaria in Europe each year. Most cases are from military personnel deployed in regions where malaria is endemic, as well as tourists returning from Africa.
Severe malaria has a mortality rate approaching 100 per cent when left untreated. However, intravenous artesunate has been shown to improve survival rates, with particular benefit for patients with high parasitaemia.
Artesunate Amivas will be sold as a 110-milligram powder and solvent which can be combined to create an injectable solution. The active substance of the medicine is artesunate, an antiprotozoal generates an unstable organic free radical which binds to malarial proteins, triggering the destruction of parasite membranes.
"Receiving approval from the European Commission to commercialise Artesunate Amivas in the EU/EEA is extremely gratifying," said Sean Power, Director of Amivas Ireland. "Now, physicians treating patients who have progressed to severe malaria will have a more satisfactory legal context for doing so, and therefore, can be even more confident in that clinical treatment decision for this very serious, but treatable, condition."