FDA approves anemia drug Jesduvroq for patients on dialysis
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The FDA has approved Jesduvroq tablets for treatment of anemia in patients with chronic kidney disease who are on dialysis, according to a press release.
The agency qualified the approval by indicating patients must be on dialysis for at least 4 months before they can be placed on Jesduvroq (daprodustat, GlaxoSmithKline[GSK]).
It is the first approved oral treatment for anemia in the United States, the agency said. “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,” Ann Farrell, MD, director of the division of nonmalignant hematology in the FDA’s Center for Drug Evaluation and Research, said in the release. “This approval demonstrates the FDA’s commitment to helping bring a range of therapeutic options to patients with chronic diseases.”
Jesduvroq is the first hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) approved by the FDA after the agency turned down new drug applications (NDA) for HIF-PHIs developed by two other drugmakers.
The Cardiovascular and Renal Drugs Advisory Committee (CRDAC), which reviews select NDAs for the FDA, voted 13-3 in October 2022 to recommend use of Jesduvroq for patients with dialysis-dependent CKD.
GSK had submitted its NDA to include use of the treatment for patients with nondialysis-dependent CKD, but the CRDAC, citing greater risks of adverse events, voted 11-5 to not recommend use of the drug for those patients.
The FDA previously declined to approve roxadustat, an HIF-PHI developed by FibroGen, and vadadustat, developed by Akebia Therapeutics.
“Over the last several decades, there has been little innovation in anemia of CKD,” Tony Wood, president and chief scientific officer for GSK, said in a press release in response to the FDA approval. “We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”
The FDA said Jesduvroq has a boxed warning for an increased risk of thrombotic vascular events, including death, heart attack, stroke and blood clots in the lungs, legs or dialysis access site. Warnings and precautions for the drug include a risk of hospitalization for heart failure, worsening increase of blood pressure and stomach erosions and gastrointestinal bleeding, according to the release.
The most common adverse events of the treatment include high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions, according to the FDA.
Reference:
- Jesduvroq (daprodustat) approved by US FDA for anemia of chronic kidney disease in adults on dialysis. https://us.gsk.com/en-us/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anemia-of-chronic-kidney-disease-in-adults-on-dialysis/. Published Feb. 1, 2023. Accessed Feb. 1, 2023.
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