By NewsDesk @bactiman63
AMIVAS Ireland Ltd., specialists in treatments for rare and neglected tropical diseases, including severe malaria, announced today the European Commission has granted approval for the Company to commercialize its lead product, Artesunate Amivas (artesunate), in EU/EEA.
The approval was based on the recent recommendation by the Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorization for the medicinal product Artesunate Amivas (artesunate), intended for initial treatment of severe malaria in adults and children.
Artesunate Amivas will be available as 110 mg powder and solvent for solution for injection.
Artesunate has had an orphan designation for Europe by the European Medicines Agency (EMA) since 2007, but until today, no marketing authorization in Europe.
Mortality from untreated severe malaria (particularly cerebral malaria) approaches 100 percent.
The European launch of Artesunate Amivas will initiate in the coming months as AMIVAS ramps up production and establishes distribution channels to meet the treatment needs of the approximately 1,250 individuals who present with severe malaria in Europe each year. Most of those cases are diagnosed in tourists to Africa and in military personnel deployed to regions where malaria is endemic.
“Receiving approval from the European Commission to commercialize Artesunate Amivas in the EU/EEA is extremely gratifying,” said AMIVAS Ireland Ltd., Director, Sean Power. “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.”
“Receiving safe, efficacious, fast-acting injectable treatment without delay is, quite literally, a life-saving imperative for a patient diagnosed with severe malaria,” said Bryan Smith, M.D., Chief Medical Officer at AMIVAS. “At AMIVAS, our expertise is in helping patients and our focus is on time. The European launch of Artesunate Amivas will be an exciting milestone to reach because of what it will mean for severe malaria patients and the physicians who care for them.”
Intravenous artesunate has been shown to improve survival in patients with severe malaria in endemic areas and the USA, with particular benefit for patients with high parasitemia. Other benefits of treatment with intravenous artesunate such as shorter intensive care unit (ICU) and hospital treatment were clearly demonstrated in European patients.
Development of Artesunate Amivas in the U.S. took place under U.S. Army Medical Research and Development Command (USAMRDC). Within USAMRDC, the Walter Reed Army Institute of Research and the U.S. Army Medical Materiel Development Activity (USAMMDA) joint collaborative work has provided the Centers for Disease Control and Prevention (CDC) a constant supply of IV artesunate since 2007. USAMMDA established a cooperative research and development agreement with AMIVAS to modernize Artesunate manufacture and register the product with the U.S. Food and Drug Administration.
European Commission approval now meets a key strategic goal to support America’s NATO Allies with an EMA-approved medical countermeasure for severe malaria.
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