Conditional Approval for Important New Drug

Varenzin-CA1 helps control potentially fatal anemia in cats with CKD

The Food and Drug Administration (FDA) conditionally approved Varenzin-CA1 (molidustat oral suspension) for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Nonregenerative anemia can be fatal because the cat’s bone marrow can’t produce enough red blood cells to replace the dead ones removed from the blood. This inhibits oxygen from being carried from the lungs throughout the body.

Current treatments include blood transfusion, supplemental iron therapy, and erythropoietin replacement (erythropoietin is a hormone that stimulates red blood cell production), although there are no erythropoietin treatments approved for cats. Varenzin-CA1 helps to increase production of erythropoietin in the kidney, which in turn stimulates the bone marrow to produce more red blood cells.

Conditional approval is often given to drugs that increase options for treating animals with uncommon, serious, or life-threatening diseases without existing adequate therapies.