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

GREENFIELD, Ind., September 07, 2023--(BUSINESS WIRE)--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.

"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 Dr. Melinda Wood, Specialty Consulting Veterinarian at Elanco. "Varenzin-CA1 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."

In a series of studies, Varenzin-CA1 was shown to have a reasonable expectation of efficacy in managing anemia in CKD cats. By day 28, 50% of cats given Varenzin-CA1 had increased their red blood cell count, and by day 56, 75% of cats had increased their red blood cell count, improving the ability to deliver necessary oxygen and nutrients to their bodies.

As a leader in feline care, Elanco has focused on bringing cutting edge products, like Varenzin-CA1, to market, in an effort to address challenges for pet owners and veterinarians, while improving the wellbeing of pets. This latest technology adds to Elanco’s existing feline portfolio, including Elura® (capromorelin oral solution) for cats, the only FDA-approved treatment specifically designed for the management of weight loss in cats with CKD. These products are helping to improve the lives of older cats and reducing the burden of care for their owners as they age.

"The bond with our pets only deepens over time," says Dr. Wood. "Unfortunately, it’s not uncommon for aging cats to be diagnosed with conditions that steal their personalities and make it hard for their owners to provide ongoing care. Elanco is uniquely offering products to address these later-stage health challenges, so cat owners no longer have to accept a sub-optimal existence for their mature and senior pets."

This conditional approval reinforces Elanco’s commitment to pioneering solutions in the underserved chronic disease state and feline market through a growing portfolio of treatment options. For more information, visit https://my.elanco.com/us/campaign/varenzin.

Varenzin-CA1 Indication

Varenzin-CA1 is indicated for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.

Varenzin-CA1 Important Safety Information

For oral use in cats only. Keep this drug, including used syringes, out of reach of children. Wash hands immediately after use. In case of accidental ingestion, seek medical advice immediately. Women who are pregnant or may become pregnant should administer the product with caution. Varenzin-CA1 should not be administered to cats that are pregnant, lactating or intended for breeding or to cats with known hypersensitivity to molidustat. Use with caution in cats with a history of seizures and in cats predisposed to thromboembolic disease. Hematocrit (HCT) or packed cell volume (PCV) levels should be monitored regularly as polycythemia may result from use of Varenzin-CA1. Varenzin-CA1 has not been evaluated in cats less than 1 year of age. The most common adverse reactions included vomiting, increases in systolic blood pressure and mild transient increase in serum potassium. Click here for full prescribing information.

Elura Indication:

Elura is indicated for management of weight loss in cats with chronic kidney disease.

Elura Important Safety Information:

For oral use in cats only. Do not use in cats that have a hypersensitivity to capromorelin or in cats with hypersomatotropism (acromegaly). Elura may increase serum glucose for several hours after dosing; use in cats with current or historical diabetes mellitus has not been evaluated and may not be appropriate. Use with caution in cats that may have cardiac disease, severe dehydration or hepatic dysfunction. Elura has not been evaluated in cats younger than 5 months of age or in breeding, pregnant or lactating cats. The most common adverse reactions included vomiting, hypersalivation, inappetence, behavior change and lethargy. Click here to see Elura product label for full prescribing information.

ABOUT ELANCO

Elanco Animal Health (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we’re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability, Elanco Healthy Purpose™– all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

ⁱ FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney Disease | FDA

ⁱⁱ 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.

ⁱⁱⁱ Boyd LM, et al. Survival in cats with naturally occurring chronic kidney disease (2000-2002). J Vet Intern Med. 2008;22:1111-17

Elura, Varenzin, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. @2023 Elanco or its affiliates.

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Contacts

Elanco Investor Contact: Katy Grissom (317) 273-9248 kathryn.grissom@elancoah.com

Elanco Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com