The U.S. Food and Drug Administration has approved Boehringer Ingelheim’s VETMEDIN to delay the onset of congestive heart failure in dogs with early-stage mitral valve disease, marking the first full FDA approval for a drug initially cleared under the agency’s conditional pathway.
The approval applies to VETMEDIN Chewable Tablets and VETMEDIN Solution, both containing the active ingredient pimobendan, for dogs diagnosed with Stage B2 preclinical myxomatous mitral valve disease, or MMVD. The authorization expands the drug’s use beyond treating symptomatic heart failure to intervening earlier, before visible clinical signs appear.
VETMEDIN: First FDA-Approved Drug to Delay Canine Heart Failure
Heart disease affects about 10 percent of dogs during their lifetime, according to industry data cited by the company. MMVD is the most common cause of heart disease in dogs and can progress silently for years before advancing to congestive heart failure, a life-threatening condition in which the heart can no longer pump blood effectively.
“This approval represents a major step forward in how veterinarians can manage canine heart disease,” said Daniel Watkins, head of U.S. pet health at Boehringer Ingelheim. “Treating dogs earlier, before congestive heart failure develops, can significantly extend both survival time and quality of life.”
Approval Marks First of Its Kind for Animal Drugs
The FDA decision is notable because it represents the first full approval of an animal drug indication that began as a conditional approval. The agency initially granted conditional approval for this use of VETMEDIN in 2022, allowing limited marketing while additional effectiveness data were collected.
Full approval was based on results from two multi-site clinical studies evaluating dogs with Stage B2 preclinical MMVD. In the pivotal EPIC study, dogs treated with VETMEDIN experienced a median delay of 15.6 months in the onset of congestive heart failure or cardiac-related death compared with dogs in the control group.
A second study found that 79 percent of dogs receiving VETMEDIN remained free of congestive heart failure for at least one year. The FDA concluded that the data met the agency’s standard for substantial evidence of effectiveness.
Veterinary cardiologists have long emphasized the challenge of managing MMVD because dogs often appear healthy while structural heart changes progress. Early diagnosis typically relies on physical exams and imaging rather than outward symptoms.
Drug Already Widely Used in Symptomatic Dogs
VETMEDIN has been used for more than 25 years to manage clinical congestive heart failure in dogs caused by MMVD or dilated cardiomyopathy, or DCM. The new approval adds an additional indication to the drug’s label, allowing veterinarians to prescribe it earlier in the disease process.
Under existing approvals, the drug is used alongside other therapies, such as diuretics, to manage mild, moderate, or severe congestive heart failure. Studies have shown that it can improve survival time and quality of life in dogs with symptomatic disease.
Boehringer Ingelheim said the safety profile of VETMEDIN remains unchanged. The company noted that the drug has not been established as safe for dogs with asymptomatic heart disease caused by conditions other than MMVD or for heart failure unrelated toMMVD or DCM. The most commonly reported non-cardiac side effects include poor appetite, lethargy, diarrhea, and vomiting.
Company Highlights Broader Impact on Animal Health
Boehringer Ingelheim, a privately held biopharmaceutical company founded in 1885, operates in both human and animal health and employs about 54,500 people worldwide. Its animal health division focuses on vaccines, parasite control products, and treatments for pets and livestock.
Company officials said the approval underscores the growing emphasis on preventive care in veterinary medicine and reflects increasing collaboration between regulators and drug developers.
“This demonstrates how conditional approvals can successfully bring innovative therapies to veterinarians sooner, while still meeting rigorous scientific standards,” Watkins said.
The company said veterinarians should consult the full prescribing information when considering VETMEDIN for individual patients.
