The United States Food and Drug Administration approved Bayer’s Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
The U.S. Food and Drug Administration approved Aurinia Pharmaceuticals Inc.’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for Mallinckrodt’s investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).
AstraZeneca’s blockbuster drug Farxiga won U.S. approval as a treatment to reduce the chances of hospitalization for heart failure in adults with type 2 diabetes and other cardiovascular risks.
The U.S. Food and Drug Administration granted fast track status for the development of AstraZeneca’s diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
Janssen’s Invokana became the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in T2D patients with CKD.
U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.
Retrophin Inc. said its drug to treat a rare kidney disorder was found effective in a mid-stage study.