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 for approval to the FDA and I believe that we are delivering a very robust data package based on the successful outcome of our pivotal Phase 3 trial and our large Phase 2b trial, which also met both the primary and key secondary endpoints. Calliditas has long been pioneering a treatment for IgAN based on precision and disease modification that focuses on the origin of the disease, with the hope of bringing help to thousands of patients, so today is truly a special day,” said CEO Renée Aguiar-Lucander.