Proveca submits a New Drug Application to the U.S. Food and Drug Administration

This press release is intended for investors only

Proveca Ltd submits a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Aqumeldi® (enalapril maleate), a prescription drug.

The submission is made for the following indications:

• Treatment of hypertension in adults and children older than one month, to lower blood pressure.
• Treatment of symptomatic heart failure.
• Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.

On 6th March 2026, Proveca submitted its first NDA in the U.S., for Aqumeldi®. Aqumeldi® is already licensed for paediatric heart failure in Europe and in the UK. This application for the conditions listed above further expands Proveca’s reach into the U.S. and will provide a new medication for both adults and paediatric patients.

The FDA review process will now be initiated and potential approval expected in H1 2027.

“Submitting the NDA for Aqumeldi® is an important milestone in Proveca’s commitment to improving the availability of evidence-based medicines specifically designed for children.” said Dr. Simon Bryson, CEO of Proveca Ltd. “If approved, Aqumeldi® has the potential to provide clinicians, families and patients in the U.S. with an innovative treatment option for managing hypertension and heart failure.”