Therapy Areas
Many medicines are administered to children. However, the majority are not licensed for use in children and are not in an age-appropriate format. This is due to the majority of medicines development traditionally focussing on adults, with little to no clinical evaluation undertaken in children; hence, licenses for paediatric use are not common and therefore this presents a large unmet medical need in children.
In 2007, the European Regulators initiated a number of developments aimed at providing incentives to companies to license existing off-patent authorised medicines for use in children. The most significant of these was the PUMA (Paediatric Use Marketing Authorisation) licensing process. Proveca obtained their first PUMA in September 2016.
This type of authorisation permits the use of a specific medicinal product, for a certain indication in the paediatric population. The development requirements of the medicine for use in children are set out in an agreed PIP (Paediatric Investigational Plan).
Proveca’s paediatric pipeline is developed through a structured identification and appraisal process, with each medicinal candidate being evaluated against a number of key factors to help identify the most appropriate options to progress through to development and licensing.
Proveca’s paediatric medicine development focus is in neurology and cardiology.
Proveca’s therapy areas focus on:
