EMA positive opinion on new PUMA product for Proveca
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EMA positive opinion on new PUMA product for Proveca.
Proveca is delighted to announce that on the 14th September 2023, the European Medicine’s Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of 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 to Adolescents). The team at Proveca have been involved in four of the eight PUMA’s granted to date. The PUMA approval is expected before the end of November 2023 and 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). It acts on the renin‑angiotensin system, blocking the formation of angiotensin II. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
The effects of Aqumeldi® in children under 18 years of age with heart failure are likely to be similar to those seen with enalapril in adults with chronic heart failure, based on the pharmacokinetic response to the medicines.
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 suffering from heart failure will be able to have access to this new 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 a formulation more appropriate for children. This PUMA provides a significant base to Proveca’s cardiology franchise.
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 children’s specific requirements.
For further information about Proveca Ltd, please visit www.proveca.com
INT-ENA-23-0042
Created September 2023