Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
In a Japanese study, approximately 1 in 8 CKD patients with anemia failed to respond to darbepoetin alfa therapy.
Tenapanor is a first-in-class oral medication that works by blocking the NHE3 transporter in the gastrointestinal tract.
In July 2020, the FDA Cardiovascular and Renal Drugs Advisory Committee narrowly voted 8 to 7 in favor of the approval of terlipressin for HRS-1.
Updated guidelines expanded to include patients with stage 1 to 5 CKD, those with kidney transplant.
The FDA concluded “the risk no longer meets the standard for a Boxed Warning.”
Transferrin saturation and ferritin concentrations improved significantly more in the ferric citrate than ferrous sulfate group over 12 weeks.
Autosomal dominant polycystic kidney disease (ADPKD) is caused by mutations of the PKD1 and PKD2 genes.
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8 to 7 in favor of the approval of terlipressin for the treatment of adults with hepatorenal syndrome type 1