The European Medicines Agency on Saturday formally authorised compassionate use of an experimental hantavirus antiviral treatment across affected EU member states, following confirmation that hospitalised patients in Germany, France, and the Netherlands have been diagnosed with hantavirus infection linked to recent exposure clusters, according to officials familiar with the regulatory decision.

The move comes one day after the EU received its first doses of the unapproved experimental therapy, with national competent authorities in Berlin, Paris, and Amsterdam now cleared to administer the drug to critically ill patients who have exhausted standard supportive care options. The EMA stressed that the authorisation does not constitute full approval and that clinical investigation protocols remain in place to collect safety and efficacy data from each treated patient.

German health authorities at the Robert Koch Institut confirmed Saturday morning that at least seven patients are currently receiving hospital-level care for severe hantavirus-related symptoms, with two cases classified as haemorrhagic fever with renal syndrome, the most dangerous clinical presentation. French public health agency Santé Publique France reported three additional confirmed cases in the Alsace region, an area historically associated with elevated rodent-borne disease risk. Dutch authorities at the RIVM are monitoring two further suspected cases in the southeastern province of Limburg.

"Compassionate use frameworks exist precisely for situations like this, where patients face life-threatening conditions and no approved therapeutic alternative is available," an EMA spokesperson said in a statement released Saturday. The agency confirmed it is working closely with the treatment's developer to establish an accelerated clinical investigation pathway that could support a conditional marketing authorisation application if early real-world outcomes are encouraging.

Public health experts cautioned that the compassionate use authorisation should not be interpreted as a signal that a broader epidemic is underway. Hantavirus is not transmitted human-to-human under normal conditions, and all current cases are believed to trace back to environmental rodent exposure rather than person-to-person spread. The European Centre for Disease Prevention and Control is expected to publish an updated rapid risk assessment by early next week, with a particular focus on whether seasonal factors — including the late-spring surge in rodent activity — are driving the current uptick in cases across central and western Europe.