Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy (IgAN). Calliditas is seeking accelerated approval under Subpart H for the 505(b)(2) application.“This is a key milestone in the company’s development and we are looking forward to engaging with the agency. This is the first time a drug specifically designed for IgAN is being submitted