CALT - Calliditas submits nefecon marketing authorisation application to the EMA

Calliditas Therapeutics (CALT) announces 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)), a form of kidney disease.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.If approved, nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, the company said.Shares up marginally during premarket trading.The U.S. FDA had given the treatment

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Calliditas submits nefecon marketing authorisation application to the EMA