Posted by Michael Wonder on 15 Mar 2021
Calliditas announces submission of new drug application to U.S. FDA for Nefecon in patients with primary IgA nephropathy
15 March 2021 - Calliditas Therapeutics today announced the submission of a new drug application to the U.S. FDA for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA nephropathy.
Calliditas is seeking accelerated approval under Subpart H for the 505(b)(2) application.
