MSD first company to receive recommendation for drug based on PIP
This article was originally published in RAJ Devices
Executive Summary
The antifungal drug Cancidas has become the first medicine to be recommended by the European Medicines Agency (EMEA) for use in children, based on clinical trial data, generated in accordance with an agreed paediatric investigation plan (PIP). The agency’s Committee for Medicinal Products for Human Use (CHMP) recently concluded that the data on the quality, safety and efficacy presented support to an extension of indication for paediatric use.