Proveca reaches agreement with EMA over heart failure drug for children

UK pharmaceutical company Proveca has reached its fourth key agreement with the European Medicines Agency (EMA) that will enable the development of a fourth drug designed specifically for children and young people.

The EMA’s Paediatric Committee (PDCO) adopted a positive opinion on the paediatric investigation plan (PIP) for the development of captopril – a drug designed to treat heart failure in children.The adoption of the PIP provides Proveca with an agreed programme for the future development of the drug. It will deliver the required quality, safety and efficacy data needed for a future licence of captopril for children throughout Europe.

Children can develop heart failure from any age. Heart failure in infants is mainly seen as a failure to thrive, with symptoms presented including poor feeding, poor weight gain and chronic breathing difficulties. Older children and adolescents present with exercise intolerance, shortness of breath, cool extremities, dizziness and fainting. Currently children need to take an adult tablet, usually crushed and suspended in a drink, or have a ‘special’ one-off liquid formulation made up each time.