Vetmedin chewable tablets receive full FDA approval for delay of congestive heart failure in dogs label indication

Approval of Vetmedin (pimobendan, Boehringer Ingelheim) chewable tablets has officially expanded to include an indication for the delay of the onset of congestive heart failure (CHF) in dogs with stage B2 preclinical myxomatous mitral valve disease (MMVD), according to the FDA’s December 19 announcement. 

Stage B2 refers to dogs with no clinical signs of heart disease but with a moderate to loud mitral murmur due to mitral valve regurgitation and cardiomegaly. 

This is the first time the FDA has granted full approval for an indication for an animal drug that was previously approved under the FDA’s expanded conditional approval authority.  

Vetmedin, available as both a chewable tablet and an oral solution, is also fully approved for the management of the signs of mild, moderate, or severe CHF in dogs due to MMVD or dilated cardiomyopathy. 

The indication for delaying the onset of CHF in dogs was conditionally approved to be added to the label for Vetmedin chewable tablets in 2022.  

Efficacy study results 

According to the FDA Freedom of Information Summary for Vetmedin, full approval for this new indication was based on the results of two multi-site field studies.  

The first one, the Evaluation of Pimobendan in dogs with Cardiomegaly (EPIC), demonstrated that pet dogs with stage B2 preclinical MMVD treated with Vetmedin developed left-sided CHF, on average, 395 days later than placebo-treated pet dogs with the same original diagnosis. The difference was so great that the study was terminated early. 

The second study used a historical control group from the EPIC study and compared it to a group of pet dogs treated with Vetmedin. The researchers defined treatment success as no radiographic evidence of CHF and no progression of clinical signs that required additional treatment after 365 days. Of the Vetmedin-treated dogs, 79.2% were classified as treatment successes. 

About expanded conditional approval 

Conditional approval for animal drugs meant for certain major uses in major species, termed expanded conditional approval, first became available in 2018. According to the FDA, expanded conditional approval was created to “incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs where demonstration of effectiveness would require a complex or particularly difficult study or studies.”  

To qualify, drug sponsors must show that the drug in question is safe and manufactured according to full approval standards, and that there is a “reasonable expectation” of the drug’s effectiveness. 

When granted, this approval is valid for one year and can be renewed up to a maximum of four annual renewals, during which time the drug sponsor must work to provide the evidence of effectiveness required for full approval.  

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