FDA grants priority review for Nefecon, for patients with IgAN

Swedish biotech Calliditas Therapeutics (STO: CALTX) says that the US Food and Drug Administration has accepted its New Drug Application for Nefecon (budesonide) for priority review as a treatment for IgA nephropathy (IgAN).

The FDA has set a Prescription Drug User Fee Act (PDUFA) target actions date for Nefecon of September 15, 2021. Calliditas’ shares roared up 9.7% to 133.40 Swedish kronor in early afternoon trading following the announcement.

“We are very excited about being granted priority review, which reflects the unmet medical need of IgAN. We look forward to engaging with the agency and work towards an accelerated approval later this year so that we will be in a position to provide the first approved medication for IgAN patients,” said chief executive Renée Aguiar-Lucander.