New PUMA product for Proveca
This Press Release is intended for the Investor Community.
New PUMA product for Proveca.
Proveca is delighted to announce that on the 15th November 2023, the European Commission granted a Paediatric Use Marketing Authorisation (PUMA) for the product Aqumeldi® (enalapril maleate) orodispersible tablets (prescription only medicine), indicated for the treatment of heart failure in children from birth to less than 18 years.
Aqumeldi® was developed under the European Commission through its 7th Framework Programme, known as LENA (Labelling of Enalapril from Neonates up to Adolescents). The excellent work carried out by the LENA consortium has now provided a new and novel formulation with data to support the treatment of children suffering from heart failure.
Aqumeldi® will be launched in several European markets over the next year.
Aqumeldi® will be available as a 0.25 mg orodispersible tablet. The active substance of Aqumeldi® is enalapril maleate, an angiotensin converting enzyme inhibitor (ACEi) (ATC code: C09AA02).
Professor Christoph Male, Department of Paediatrics, Medical University of Vienna, LENA Investigator – On behalf of the LENA Consortium, we are delighted that Proveca has received a PUMA licence for the enalapril orodispersible tablet. The data we provided from this trial will give clinicians the confidence to treat children with an age-appropriate formulation and with a dose licenced for the indication of heart failure. This will hugely benefit children throughout Europe.
Dr Simon Bryson, CEO, Proveca– This new PUMA for Aqumeldi® will be the first product to be launched in our cardiology portfolio and we are delighted that children throughout Europe, suffering from heart failure, will be able to have access to this new and innovative orodispersible mini tablet formulation, which has been designed with the young child in mind.
Dr Helen Shaw, Chief Medical Officer, Proveca– Medication adherence can be particularly challenging for many young children, especially those who are chronically ill and require strict adherence due to their condition. Aqumeldi® contains the ACE inhibitor enalapril maleate, in a lower dosage strength than existing tablets and in an innovative formulation more appropriate for children. This PUMA provides a significant platform to Proveca’s cardiology franchise and is based on a body of newly generated clinical data in the patient population.
Please click here for the link to the Aqumeldi (enalapril maleate) Product Information (containing the Summary of Product Characteristics).
About Proveca
Proveca is a European pharmaceutical company who specialise in the development and licensing of medicines to address the unmet medical needs of children.
Working with clinicians, parents, carers and children, Proveca are leading the way to provide licensed medicines that are tailored to childrens specific requirements.
For further information about Proveca Ltd, please visit www.proveca.com.
INT-ENA-23-0051
Created November 2023