Positive opinion received from EMA Paediatric Committee on the Paediatric Investigation Plan for Nefecon for the treatment of IgAN
Calliditas Therapeutics AB (publ) (“Calliditas”) today announced that the EMA Paediatric Committee (PDCO) has adopted a positive opinion on the Paediatric Investigation Plan (PIP) for Nefecon for the treatment of primary IgA nephropathy (IgAN).With successful completion of the agreed PIP, Nefecon would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP