Combatting malaria: AMIVAS launches first fully regulated injectable solution in Europe

AMIVAS Ireland Ltd has announced the launch of Artesunate AMIVAS, the first and only licensed treatment for severe malaria in Europe and the UK. Approved by the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Artesunate AMIVAS is now available to treat severe malaria in both children and adults. The drug is distributed across Scandinavian countries including Denmark, Finland, Sweden, and Norway through Nordic Prime.

Severe malaria, a life-threatening disease, affects an estimated 1,250 travellers in Europe annually, mostly military personnel and civilian travellers returning from malaria-endemic regions. Without timely intervention, severe malaria has a near 100% mortality rate, making rapid access to approved treatments essential for saving lives. Artesunate AMIVAS is designed to fill this critical gap by providing a licensed and regulated solution for European healthcare systems.

Artesunate AMIVAS is available as a 110-milligram powder that, when combined with a solvent, forms an injectable solution. This formulation, previously approved and distributed in the United States, has shown strong efficacy in reducing malaria-related mortality rates in clinical trials such as the SEAQUAMAT and AQUAMAT studies. In these trials, Artesunate was found to reduce mortality by up to 35% compared to traditional quinine-based treatments.

AMIVAS Operations Director, Laura Walsh, emphasised the significance of this launch, stating that the availability of Artesunate AMIVAS in Europe ensures that healthcare providers have a reliable, approved solution for treating severe malaria cases. She noted that the established safety and efficacy profile of the drug gives medical professionals confidence when administering it to patients of all age groups, including children and pregnant women.

Sean Power, Director of AMIVAS Ireland Ltd, commented that the launch in Europe follows the successful rollout of the product in the US, underscoring the company’s commitment to delivering lifesaving treatments for neglected tropical diseases globally. He expressed that the mission of AMIVAS remains focused on providing effective solutions to regions where malaria poses a critical threat.

The European Union Commission granted approval for the commercialisation of Artesunate AMIVAS in the EU and EEA regions in 2021, while the MHRA approved its use in the UK in April 2022. AMIVAS has highlighted that this milestone represents a strategic achievement in supporting NATO allies and European civilians with a reliable countermeasure for severe malaria.

The launch of Artesunate AMIVAS in Europe marks a crucial development in the global fight against malaria. Experts highlight that the rapid and effective administration of the drug can be lifesaving, especially in high-risk groups such as young children, pregnant women, and individuals without prior immunity. The distribution partnership with Nordic Prime ensures that this vital treatment reaches key markets across Scandinavia, providing a safety net for those at risk of severe malaria infection.