Elanco Launches Varenzin-CA1 (molidustat oral suspension) – the First-of-its-Kind Oral Treatment for Anemia in Cats with Chronic Kidney Disease

Today, Elanco Animal Health Incorporated (NYSE: ELAN) announced that the first shipments of Varenzin-CA1 (molidustat oral suspension), conditionally approved by U.S. Food and Drug Administration (FDA) as the first and only treatment to control non-regenerative anemia in cats with chronic kidney disease (CKD), 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.ⁱ 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.”

CKD-related anemia stops cats’ bone marrow from producing 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 common among mature and senior cats, occurring in about 15-30% of feline patients over 12 years old. Anemia is a common finding in over half of all CKD-diagnosed cats.ⁱⁱ However, prior to Varenzin-CA1, less than one-third of anemic cats received treatment.ⁱⁱⁱ This latest innovation from Elanco addresses an unmet need for this chronic condition in mature cats and furthers Elanco’s feline portfolio aimed at keeping cats healthy throughout their lives, especially as they age.