Calliditas Therapeutics AB (NASDAQ: CALT) announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires this week.
“We were pleased to share additional analyses from the two-year Phase 3 NeflgArd trial of Nefecon in IgAN at this year’s World Congress of Nephrology,” said Chief Medical Officer Richard Philipson. “These additional data further reinforce the impact of Nefecon across the entire study population, irrespective of baseline UPCR levels or patient’s racial and ethnic backgrounds.”
TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations.
According to Thursday morning’s news release, atients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).
Shares in CALT closed Wednesday at $18.74.
