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Calliditas Announces Submission of Marketing Authorisation Application for Nefecon to the European Medicines Agency News provided by Share this article Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ( Calliditas ) today announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN). The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The study achieved its primary endpoint of proteinuria reduction compared to placebo, and also showed a renal protective effect by way of stabilization of eGFR at 9 months.

United statesMarie galayExchange commissionEuropean medicines agencyCommittee for human medicinal productsNasdaq stockholmMarketing authorisation applicationIga nephropathyAccelerated assessmentHuman medicinal productsNasdaq global select marketPrivate securities litigation reform actCalliditas therapeuticsHealth care amp hospitalsMedical pharmaceuticalsClinical trials amp medical discoveries