Artesunate AMIVAS is now available for purchase in the UK and Ireland. Artesunate AMIVAS is approved by the EU Commission to treat severe malaria both in children and adults in Europe, and is the only fully licensed such product.
Annually, about 1,250 individuals in Europe are diagnosed with severe malaria; most cases are either military personnel deployed to malaria-endemic regions of the world or civilian travellers returning from a visit to those regions. Severe malaria has a mortality rate approaching 100 per cent when left untreated; infant, children and pregnant women are among those at highest risk.
AMIVAS Ireland Ltd (AMIVAS), is a biopharmaceutical company based in Waterford City, Ireland. It is focused on developing, commercialising, manufacturing and distributing artesunate for the treatment of severe malaria. Today it announced the availability of Artesunate AMIVAS in the UK and Ireland. This follows the European launch last month.
Artesunate AMIVAS is the first and only product licensed, manufactured in a regulated setting, and approved to treat severe malaria in the EU and European Economic Area (EEA). Severe malaria is a disease that impacts an estimated 1,250 European travelers each year. Artesunate AMIVAS is sold as a 110-milligram powder and solvent combined to create an injectable solution.
“The availability of Artesunate AMIVAS across Europe means that, for the first time, travellers to and from malaria-endemic regions of the world, and European military personnel deployed there, now have access to a licensed, approved severe malaria treatment that could save their lives if needed”, said Laura Walsh, AMIVAS Operations Director. “Because of the well-established safety and efficacy profile of Artesunate AMIVAS, healthcare practitioners can now be confident when treating an adult or child diagnosed with severe malaria.”
“It is gratifying to be launching Artesunate AMIVAS in Europe after its successful launch in the United States”, said Sean Power, AMIVAS Director, Ireland. “The AMIVAS mission is focused on bringing safe, effective, fully licensed and approved treatments to patients in need in order to extend and improve their lives. This milestone is clear proof of our commitment to that pledge.”
The U.S. Food and Drug Administration approved Artesunate for Injection™ in May, 2020 to treat severe malaria in adults and in children. AMIVAS Inc holds the license. The European Union Commission awarded approval to AMIVAS Ireland to commercialise Artesunate AMIVAS in the EU and EEA in late 2021.
About Severe Malaria
Malaria is a febrile disease caused by Plasmodium parasites and transmitted by mosquitos. In 2020, almost half of the global population was at risk of contracting malaria. Over 400,000 deaths are recorded each year from the disease, with sub-Saharan Africa’s population being most at risk. In Europe, 50 years after eradication, malaria is still a major health concern. While most infections in Europe are related to international travel, climatic changes are foreseen to enhance the risk for locally transmitted malaria infections in Europe in the future. In Europe, peaks in the number of malaria cases occur during July to September. Since the vast majority of malaria cases are imported, this could at least partly be linked to travellers returning from summer holidays. Malaria can progress to severe malaria, at which point the mortality rate approaches 100 percent if left untreated. Infants and children under five, pregnant women, and people with low immunity are at highest risk of developing severe malaria.1. Complications of severe malaria include severe anaemia and signs of end-organ damage, such as coma (cerebral malaria), lung complications, hypoglycaemia (low glucose blood levels), or acute kidney injury.
About Artesunate AMIVAS
Intravenous artesunate has been the global standard of care for severe malaria for more than 20 years. Artesunate AMIVAS is approved for the initial treatment of severe malaria in adults and children by the U.S. Food and Drug Administration, the European Medicines Agency, and the Medicine and Healthcare Product Regulatory Agency.
Artesunate is associated with up to a 34.7 percent reduction in risk of mortality compared with quinine. Supplied as a sterile powder, Artesunate can be safely stored at room temperature. Artesunate Amivas is easily prepared for use in one step.
Artesunate AMIVAS is superior to standard intravenous quinine in the most important clinical parameter, mortality. Artemisinins, the active ingredient in Artesunate AMIVAS, are fastest-acting clinical anti-malarial compounds. They can be administered intravenously only when formulated to do so.
About AMIVAS
AMIVAS, based in Delaware, is a post-approval biopharmaceutical company, founded with a mission to improve and extend human lives by discovering, developing, and distributing new best-in-class medicines. AMIVAS responded to the urgent need for a United States- and European-based firm to assume responsibility for regulated manufacture and distribution of Artesunate after quinidine gluconate was discontinued in the U.S. in 2019. The Company achieved U.S. Food and Drug Administration approval for Artesunate for Injection – its first commercial product – in May, 2020. Artesunate for Injection is indicated for the initial treatment for severe malaria in adults and children. AMIVAS is committed to being the global leader in the battle against infectious diseases, driving scientific discovery and breakthroughs that will redefine the possibilities of critical medicines.
For more information, visit AMIVAS.com and follow AMIVAS on LinkedIn.
To order Artesunate AMIVAS see www.amivas.com or https://www.nordicprime.dk (Scandinavian markets)
References:
- European Climate and Health Observatory, Malaria Fact Sheet, published May, 2023. https://climate-adapt.eea.europa.eu/en/observatory/evidence/health-effects/vector-borne-diseases/malaria-factsheet. Accessed on 21 September, 2024.