EU Commission Grants AMIVAS Ireland Ltd. Approval to Market Artesunate Amivas (artesunate) in the EU/EEA for Initial Treatment of Severe Malaria

WATERFORD, Ireland, Nov. 24, 2021 /PRNewswire/ -- 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 authorisation 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 parasitaemia. 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.

Where to Find More Information
The product information approved by the Committee for Medicinal Products for Human Use (CHMP) for Artesunate Amivas contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the Artesunate Amivas authorisation. An assessment report, with details of the EMA evaluation of Artesunate Amivas, is available on the EMA's website. Also available there is an overview of Artesunate Amivas written in lay language, including a description of the medicine's benefits and risks and a description of why EMA recommended Artesunate Amivas authorisation in the EU. For more information about Artesunate Amivas, including the Summary of Product Characteristics and Patient Information Leaflet in respective European languages, visit www.AMIVAS.eu or www.ema.europa.eu/en/medicines/search.

Clinical Studies
The safety and efficacy of IV Artesunate were studied in three trials including the South-East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) and the African Quinine Artesunate Malaria Trial (AQUAMAT). These two studies examined a total of 6,886 patients and included adults, children and pregnant women. IV Artesunate reduced mortality by 34.7 percent and 22.5 percent compared with the injectable standard of care drug in the SEAQUMAT and AQUAMAT studies respectively. Data were also collected between January 2007 and December 2010 on 102 U.S. patients with severe or complicated malaria who were supplied IV Artesunate under the CDC expanded access protocol. Ninety-two patients received at least one administration of drug at 0, 12, 24 and 48 hours. These U.S. patients included adults, children, pregnant women and older adults. Most were Black or African American, 25 percent were White, 9 percent were Asian. Seven patients died from complications of severe malaria (mortality rate, 6.9 percent). Primary funding source for the data analysis from patients enrolled in the CDC study was the Office of the Surgeon General, Department of the U.S. Army. While no service personnel were actively recruited into any of the clinical trials of IV Artesunate, several service members were offered emergency treatment under the CDC protocol.

To report SUSPECTED ADVERSE REACTIONS, contact AMIVAS Ireland Ltd. at MICC.AMIVAS@4cpharma.com. In other countries, refer to the following telephone numbers, respectively:

About Malaria and Severe Malaria
Malaria is one of the world's leading killers of people, especially children. Severe malaria, a medical emergency, typically includes neurologic symptoms, severe anaemia, acute renal injury, acute respiratory distress syndrome, or jaundice, as a large number of the patient's red blood cells become infected by a malaria parasite. Uncomplicated falciparum malaria can progress rapidly to severe forms of the disease, especially in people with no or low immunity. Without treatment, severe falciparum malaria is almost always fatal.

Prompt, effective treatment within 24 - 48 hours of the onset of malaria symptoms is necessary. 

A rare disease, malaria is not always recognised, diagnosed and treated in timely fashion. Nearly all cases in Europe occur in persons who acquire the infection while in a malaria endemic area and who are diagnosed after returning to their home area. Most have no acquired immunity to malaria and are, therefore, at risk of developing severe malaria. A major contributing factor to continued malaria-associated mortality in is delay in initiation of appropriate treatment. Malaria chemoprophylaxis and the use of bed nets and insect repellants help reduce the risk of contracting malaria. 

About AMIVAS
AMIVAS is a U.S. joint venture focused on the development, manufacture and commercialization of therapeutic products for the treatment of infectious diseases. Headquartered in Frederick, Maryland, AMIVAS was formed in 2016 expressly for the purpose of bringing treatments to market for rare and neglected tropical diseases. AMIVAS Ireland Ltd. is a wholly owned subsidiary of AMIVAS and is responsible for the European markets.

Disclaimer: The views expressed in this release are those of the author and do not necessarily represent the views of the U.S. Army or the Department of Defense (DoD) or U.S. CDC. Discussion of specific pharmaceutical products does not reflect an endorsement of those products.

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