The U.S. Food and Drug Administration conditionally approved Varenzin-CA1 (molidustat oral suspension), the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Nonregenerative anemia can be a fatal condition because the cat’s 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, resulting 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 can develop CKD at any age, but it is frequently diagnosed in older cats. It can be triggered by other diseases or malformation of the kidneys, bacterial or viral infections, kidney inflammation and associated damage (glomerulonephritis), cancers, or a build-up of protein in the kidney (amyloidosis).
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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. 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 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,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine. “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.”
Under conditional approval, the FDA has concluded that the drug is safe for its intended purpose and has a reasonable expectation of being effective. This allows cats suffering from the disease 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.
SOURCE: PR Newswire