The U.S. Food and Drug Administration recently approved of a drug from Ceva Animal Health used for the management of congestive heart failure in dogs brought on by atrioventricular valvular insufficiency (AVVI). Cardalis, which has been prescribed in Europe since 2012, is a chewable tablet that contains spironolactone and benazepril hydrochloride.

Until now, dogs with AVVI had been treated with these same active substances via the off-label use of products approved for humans.

“Today’s approval is novel because the drugs are now approved in a combination found to be safe and effective for canine patients,” reads the July 28 report from the FDA. Cardalis will be made available in three dosages (2.5 mg benazepril hydrochloride/20 mg spironolactone, 5 mg/40 mg, and 10 mg/80 mg) and packaged in bottles of 30.

Any dog can get AVVI, but it is especially common among older, smaller breeds, including Cavalier King Charles Spaniels, Dachshunds, Miniature and Toy Poodles, Chihuahas, and Yorkshire Terriers.

The drug was determined to be safe and effective in a 12-month field study that looked at 569 dogs with the disease:

In the study Cardalis was compared to the active control, benazepril hydrochloride, for the management of clinical signs of congestive heart failure in dogs due to AVVI, and to demonstrate the contribution of spironolactone to the effectiveness of the Cardalis combination drug product.

Another study found that healthy dogs were able to tolerate the drug at up to five times the recommended maximum dosage for a period of six months, further demonstrating its safety.

As the FDA’s report notes, AVVI is the most common form of heart disease among dogs, affecting up to 85% of small breeds by the age of 13. Fortunately, if detected early on and treated by a veterinarian with the proper medication, it can be managed.