FDA approves Jesduvroq for CKD-caused anemia in dialysis patients

Having twice previously declined to approve two other products in the class, the US Food and Drug Administration has now granted marketing authorization for UK pharma major GSK’s (LSE: GSK) Jesduvroq (daprodustat) tablets as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease in adults on dialysis.

Jesduvroq is the first innovative medicine for anemia treatment in over 30 years and the only HIF-PHI approved in the USA, providing a new oral, convenient option for patients in the US with anemia of CKD on dialysis.

Other FDA-approved therapies for this condition are injected into the blood or under the skin. It is important to note that Jesduvroq is not approved for patients with chronic kidney disease who are not on dialysis because of serious risks in that population. This is a disappointment for GSK, which had hoped for an FDA green light to treat patients who don't require dialysis.