Elanco says first shipments of Varenzin-CA1 conditionally approved by FDA

Elanco Animal Health announced that the first shipments of Varenzin-CA1, conditionally approved by U.S. Food and Drug Administration as the first and only treatment to control non-regenerative anemia in cats with chronic kidney disease, are shipping to veterinary clinics around the country. Anemia from CKD can dramatically affect a cat’s existence, making them lethargic, reducing their appetite, and even leading to a rapid heart rate and difficulty breathing in severe cases. According to the FDA, CKD-related anemia is a complication that often contributes to death or euthanasia of affected cats due to poor quality of life. The challenges of current therapy to address this devastating condition often include inconvenient and extra-label use of a human drug. “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 the FDA Center for Veterinary Medicine, upon conditionally approving the product. “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.”