Elanco US Inc. has received conditional approval for Varenzin-CA1, the first drug formulated to treat nonregenerative anemia associated with feline chronic kidney disease.
Nonregenerative anemia can be a serious complication for CKD-afflicted cats, reducing their quality of life and contributing to death or euthanasia. Chronic kidney disease affects about 30% of cats older than 10, and anemia is noted in about 32% to 65% of those patients.
Typically, cats with CKD-related nonregenerative anemia receive blood transfusions, supplemental iron therapy and erythropoietin replacement. Currently, no erythropoietin treatments are approved for feline use, and a high percentage of cats treated off-label with erythropoietin replacement therapy suffer adverse effects, such as polycythemia, systemic hypertension, iron depletion, injection site reactions, allergic reactions and seizures.
Varenzin’s active ingredient, molidustat, is a hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor that increases endogenous erythropoietin production, which stimulates hemoglobin and red blood cell production. In addition to addressing erythropoietin deficiency, the main cause of CKD-related anemia, HIF-PH inhibition might increase iron availability for erythropoiesis.
Research showed that Varenzin demonstrated a reasonable expectation of effectiveness and an acceptable safety profile for the control of nonregenerative anemia associated with CKD in cats.
The drug is administered orally once a day for up to 28 days.
Potential adverse side effects include vomiting, increased systolic blood pressure and thromboembolism.
Varenzin was granted conditional approval under the U.S. Food and Drug Administration’s Animal Drug User Fee Act of 2018. Veterinary drugs that address a serious or life-threatening condition or an unmet animal or human health issue but would require complex or particularly difficult studies to demonstrate their effectiveness are eligible for approval.
“This is the first drug for cats under expanded conditional approval, a pathway to the marketplace that encourages development of innovative treatments and increases options for treating animals with uncommon conditions, serious life-threatening diseases, or diseases without existing or adequate therapies,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine.