Novel drug for anemia in cats with CKD arrives on the US market

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A new oral treatment indicated to control nonregenerative anemia in cats with chronic kidney disease (CKD) has been launched on the veterinary market.¹ Molidustat oral suspension (Varenzin-CA1; Elanco Animal Health) was conditionally approved by the FDA in May 2023.^2,3 It is the first drug for cats to receive the conditional approval designation, which serves as a pathway for development of innovative treatments that target conditions that are uncommon, life-threatening or serious, and those without existing or adequate therapies.²

To receive conditional approval, molidustat oral suspension was evaluated in a 2-phase multi-center, randomized, placebo-controlled field effectiveness and safety study. The first phase was double-masked, while the second phase was an unmasked, optional continuation of the investigation. Both study phases enrolled 23 cats from age 4 to 17 years, of various breeds and mixes that were diagnosed with nonregenerative anemia associated with CKD.³

Anemia from CKD can make feline patients lethargic and reduce their appetite, and lead to a rapid heart rate and difficulty breathing, in severe cases, according to Elanco Animal Health.¹ Additionally, CKD-related anemia often contributes to death or euthanasia of cats with the condition because of their poor quality of life. Current therapies used to address CKD-related anemia often include extra-label use of a human drug, blood transfusion, and supplemental iron therapy.²

CKD is common among mature and senior cats, occurring in about 15% to 30% of feline patients over the age of 12 years. Furthermore, anemia is common in more than half of all cats diagnosed with CKD.⁴ “Chronic kidney disease is not curable, so veterinarians and pet owners are focused on improving quality of life and slowing disease progression in affected cats,” said Melinda Wood, DVM, specialty consulting veterinarian at Elanco, in an organizational release. “[Molidustat oral suspension] is an innovative, needle-free oral suspension option for cats that can be given at-home—no in-clinic injections needed. This innovation sets a new standard of care for cats suffering from the debilitating effects of this disease. It represents a paradigm shift in the early-treatment of CKD-related anemia and helps CKD cats feel more like their feline selves.”¹

In a series of studies, molidustat oral suspension was shown to have a reasonable expectation of efficacy in managing anemia in CKD cats. By day 28, 50% of cats given the drug had increased their red blood cell count, and by day 56, 75% of cats had increased their red blood cell count, which improved oxygen and nutrient delivery to their bodies. The most commonly reported adverse reactions included vomiting, increases in systolic blood pressure and mild transient increase in serum potassium.¹

References

1. Elanco Launches Varenzin-CA1 (molidustat oral suspension) – the First-of-its-Kind Oral Treatment for Anemia in Cats with Chronic Kidney Disease. News release. Elanco. September 7, 2023. Accessed September 12, 2023. https://www.elanco.com/en-us/news/elanco-launches-varenzintm-ca1-molidustat-oral-suspension
2. FDA conditionally approves first drug for anemia in cats with chronic kidney disease. News release. FDA. May 1, 2023. Accessed September 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-drug-anemia-cats-chronic-kidney-disease
3. FDA conditionally approves first drug for anemia in cats. dvm360. May 2, 2023. Accessed September 12, 2023. https://www.dvm360.com/view/fda-conditionally-approves-first-drug-for-anemia-in-cats
4. Chalhoub S, et al. Anemia of renal disease: what it is, what to do and what's new. J Feline Med Surg. 2011;13(9):629-40.