First torsemide drug for dogs received conditional approval
This initial conditional approval is valid for 1 year with the potential for 4 annual renewals
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The FDA has issued a conditional approval for the first torsemide drug for dogs (UpCard-CA1; Vetoquinol). This drug is intended to be used alongside concurrent medications including pimobendan, spironolactone, and angiotensin-converting enzyme (ACE) inhibitors. This therapy combination will help manage pulmonary edema, a buildup of fluid in the lungs seen in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).1
MMVD is an abnormality in the heart valve or muscle that prevents the valve from closing properly and should be diagnosed by a veterinarian through thorough physical and cardiac evaluations.1 This abnormality affects the heart's ability to pump blood efficiently and can lead to an enlarged heart (cardiomegaly). If left untreated, MMVD can progress to congestive heart failure, causing fluid buildup in the chest and abdomen. MMVD is prevalent across various dog breeds, with a higher occurrence in smaller breeds such as Cavalier King Charles spaniels, Yorkshire terriers, and dachshunds. At the 2023 American College of Veterinary Internal Medicine (ACVIM) forum in Philadelphia, Pennsylvania, third year cardiology resident at Texas A&M University, Tess Sykes, DVM presented a poster on the link between cardiac complications including MMVD in Borzoi dogs.
According to the FDA and Vetoquinol, UpCard-CA1 is packaged in vials containing 32 or 96 mL and should be administered orally once daily at a dose of 0.05 to 0.2 mg/lb (0.11 to 0.44 mg/kg) of bodyweight.1
The FDA allows drugs treating serious or life-threatening diseases in animals to be marketed after demonstrating safety and manufacturing standard before receiving full approval. The organization allows recognized the difficulty this disease poses for gathering effective studies as it would be time consuming and difficult to gather a large data pool.1 Therefore, the FDA has deemed UPCard-CA1 has met the necessary requirements for expanded conditional approval.
However, during the conditional approval time, Vetoquinol must demonstrate that it is actively working toward collecting the remaining effectiveness data needed to achieve full approval. Full approval must be attained within 5 years after receiving conditional approval, or this drug will no longer be in effect.1
Reference
FDA conditionally approves first torsemide animal drug for dogs. News release. FDA. May 10, 2024. Accessed May 13, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-conditionally-approves-first-torsemide-animal-drug-dogs
