The U.S. Food and Drug Administration conditionally approved Elanco US Inc.'s Varenzin-CA1 (molidustat oral suspension) for treating anemia in cats with chronic kidney disease or CKD.
It is the first drug for the control of nonregenerative anemia associated with CKD in cats. Varenzin-CA1 works by helping to increase production of erythropoietin in the kidney, which in turn stimulates the bone marrow to produce more red blood cells.
Varenzin-CA1 is a liquid given by mouth to the cat once daily for up to 28 days. The treatment may be repeated as needed after a minimum seven-day pause. The drug is available only by prescription from a licensed veterinarian.
For cats, nonregenerative anemia can be a fatal condition as their bone marrow is not able to produce enough red blood cells to replace the older or damaged red blood cells that are naturally removed from the blood. This would result in the inability for oxygen to be carried from the lungs throughout the body.
CKD is a disease that requires day-to-day management in cats, and nonregenerative anemia is a complication that often contributes to death or euthanasia of affected cats due to poor quality of life. Cats with CKD develop nonregenerative anemia when their kidneys produce less of a hormone called erythropoietin, which helps the bone marrow produce red blood cells.
The agency noted that the current treatments available for nonregenerative anemia in cats with CKD include blood transfusion, supplemental iron therapy and erythropoietin replacement. However, there are no erythropoietin treatments approved for use in cats.
Under conditional approval, the FDA has concluded that Varenzin-CA1 drug is safe for its intended purpose and has a reasonable expectation of being effective. This allows the affected cats to receive the treatment while full effectiveness data is being collected.
The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval.
The agency noted that the product can no longer be marketed if a sponsor does not meet the requirements for substantial evidence of effectiveness at the five-years mark.
Tracey Forfa, director of the FDA's Center for Veterinary Medicine, said, "Varenzin-CA1 is the first drug to receive conditional approval for use in cats, providing access to a novel medicine for our feline companions suffering from nonregenerative anemia due to CKD. Additionally, this is the first drug for cats under expanded conditional approval, a pathway to the marketplace that encourages development of innovative treatments and increases the options for treating animals with uncommon conditions, serious or life-threatening diseases, or diseases without existing or adequate therapies."
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