FDA Panel Votes on Daprodustat for Anemia of Chronic Kidney Disease
The NDA was supported by data from the ASCEND clinical program, which included dialysis and nondialysis patients.
The NDA was supported by data from the ASCEND clinical program, which included dialysis and nondialysis patients.
KP104 is a bifunctional, first-in-class biologic that works by selectively inhibiting the alternative and terminal pathways in the complement system.
Anemia can identify patients at higher risk for radical cystectomy complications and may be useful in preoperative counseling, according to investigators.
Changes in anemia care associated with lower risks for major adverse cardiovascular events, stroke, mortality, heart failure
Nearly 24% of patients with advanced CKD, including those on dialysis, have gout, according to a study.
In a study of incident dialysis patients, the HIF-PHI agent daprodustat demonstrated safety and efficacy similar to that of the ESA darbepoetin alfa.
The NDA submission included data from 36 clinical trials involving over 8000 patients.
By clarifying the risk for anaphylaxis, study findings can contribute to the choice of IV iron preparations, according to investigators.
Organization has had to limit blood product distributions to hospitals
People who have received COVID-19 vaccines can donate blood and platelets as long as they are symptom-free