GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.
Jesduvroq is the first FDA-approved oral treatment for anemia caused by CKD for adults on dialysis, as other FDA-approved treatments for this condition are injected under the skin or into the blood.
CKD is estimated to affect around 700 million people in the world, and about one in seven patients also develop anemia, a complication of CKD. Poor clinical outcomes can result if anemia of CKD is untreated or undertreated, and this burdens patients and healthcare systems.
“With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia,” said Ann Farrell, MD, director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, in the FDA’s press release.
“This approval demonstrates the FDA’s commitment to helping bring a range of therapeutic options to patients with chronic diseases. Patients can consult with their healthcare providers to select the option that is most appropriate,” added Dr. Farrell.
How Does Jesduvroq (daprodustat) Work?
Erythropoietin is a hormone that is produced by the kidneys and signals the body to make red blood cells. In an individual with CKD on dialysis, the kidneys cannot make enough erythropoietin, which leads to decreased numbers of red blood cells (anemia).
Jesduvroq works by increasing erythropoietin levels. Jesduvroq is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). By inhibiting oxygen-sensing prolyl hydroxylase enzymes, Jesduvroq stabilizes hypoxia-inducible factors, and this can lead to the transcription of erythropoietin and other genes that help correct anemia.
XTALKS WEBINAR: Patient Centric Sampling: Bringing the Clinical Trials to the Patient
Live and On-Demand: Wednesday, March 15, 2023, at 11am EDT (4pm CET/EU-Central)
Register for this free webinar to learn more about patient centric sampling and how decentralized and hybrid approaches bring clinical trials directly to the patient.
Clinical Trial Outcomes
The FDA approval of Jesduvroq is based on results from the Phase III ASCEND-D trial, which were published in the New England Journal of Medicine.
ASCEND-D was a randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center trial. The study assessed the efficacy and safety of daprodustat in 2,964 individuals with anemia associated with CKD. The study participants had to be on dialysis for more than 90 days prior to screening and continuing the same mode of dialysis from screening (Week -8) through to Day 1 of the study.
The study participants received either oral daprodustat or injected recombinant human erythropoietin (a standard of care [SOC] treatment for patients with anemia associated with CKD). In addition, a uniform iron management protocol was implemented across both arms of the study.
The ASCEND-D study met its primary efficacy and safety endpoints. Daprodustat improved or maintained hemoglobin (Hb) within target levels (10 to 11.5 g/dL), similar to that of the SOC arm.
The most common side effects of Jesduvroq include high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions.
Tablets of Jesduvroq will be available in five dosage strengths: 1mg, 2mg, 4mg, 6mg and 8mg.
“Over the last several decades, there has been little innovation in anemia of CKD. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options,” said Tony Wood, President and Chief Scientific Officer, GSK, in the company’s press release.
Join or login to leave a commentJOIN LOGIN