EMA panel recommends PIP of budesonide to treat IgA nephropathyMarch 6, 2020
The EMA Paediatric Committee (PDCO) has adopted a positive opinion on the Paediatric Investigation Plan (PIP) for targeted release budesonide for the treatment of primary IgA nephropathy (IgAN).
With the successful completion of the agreed PIP, the drug 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.
Acceptance of this PIP paves the way for the potential submission of an MAA in Europe following completion of Part A of the ongoing phase 3
trial NefIgArd, Calliditas Therapeutics AB said.