CUTISS receives Positive Opinion from the Paediatric Committee of the EMA for denovoSkin™

 CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced that it received a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) for its proposed Paediatric Investigation Plan (PIP) for denovoSkin™.

The positive opinion is based on the non-clinical program, as well as data from the phase I safety clinical trial and the plans for the current phase IIb efficacy trials running in children and adults. The PDCO’s positive opinion on CUTISS’ PIP endorsed the Company’s program for denovoSkin™ as acceptable for assessment of safety and efficacy for the use in children from birth  to less than 18 years of age.

The relevance of a Paediatric Investigation Plan (PIP)
A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when a marketing-authorisation holder wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorised and covered by intellectual property rights.