Posted by Michael Wonder on 30 May 2021
Calliditas announces submission of marketing authorisation application for Nefecon to the European Medicines Agency
28 May 2021 - Calliditas Therapeutics today announced that the company submitted a marketing authorisation application to the EMA for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA nephropathy.
The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 trial, a randomised, double-blind, placebo-controlled, international multi-center study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgA nephropathy.
