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  5. FDA Conditionally Approves First Torsemide Animal Drug for Dogs
  1. CVM Updates

FDA Conditionally Approves First Torsemide Animal Drug for Dogs

May 10, 2024

Today, the U.S. Food and Drug Administration conditionally approved UpCard-CA1 (torsemide oral solution) for use with concurrent therapy with pimobendan, spironolactone, and an angiotensin-converting enzyme (ACE) inhibitor for the management of pulmonary edema (fluid build-up in lungs) in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD). 

MMVD is a disease in dogs where an abnormal heart valve or muscle does not allow the heart valve to close completely, impacting the ability of the heart to pump blood and resulting in an enlarged heart (cardiomegaly). If left untreated, this condition may lead to heart failure and fluid accumulation in the chest and abdomen (congestive heart failure). MMVD occurs in many breeds of dogs. It most frequently occurs in smaller breed dogs, including Cavalier King Charles Spaniels, Yorkshire terriers, and dachshunds. MMVD should be diagnosed by a veterinarian based on comprehensive physical and cardiac examinations.  

An animal drug that addresses a serious or life-threatening disease, or addresses an unmet animal or human health need, for which demonstrating effectiveness would require a complex or particularly difficult study or studies is eligible for expanded conditional approval. This allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of effectiveness for use. Congestive heart failure caused by MMVD is a serious and life-threatening disease in dogs because it’s fatal when not treated. Due to the nature of the disease, it would be time consuming and difficult to enroll sufficient numbers of eligible dogs in effectiveness studies. Additionally, diagnosis requires advanced and complicated tests. Therefore, the FDA determined that UpCard-CA1 met the eligibility criteria for expanded conditional approval.

The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate that it is actively working toward collecting the remaining effectiveness data needed to achieve full approval. The animal drug sponsor must attain full approval within five years after receiving conditional approval, or it will no longer be in effect. 

UpCard-CA1 is available as a solution that is packaged in vials containing 32 or 96 mL. UpCard-CA1 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.

UpCard-CA1 is sponsored by Vetoquinol USA, Inc. based in Fort Worth, Texas.

For more information:

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

 

 
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