FDA grants conditional approval for drug delaying start of congestive heart failure in canines

Officials with the FDA have granted conditional approval to Boehringer Ingelheim Animal Health's pimobendane oral tablets (Vetmedin-CA1) for delaying the onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD), according to the company. This conditional approval is the first for a drug indicated to treat canines within the preclinical stage of MMVD that show signs of a heart murmur and an abnormally enlarged heart but are not yet in congestive heart failure.¹

A previously approved pimobendane product from Boehringer Ingelheim (Vetmedin) is indicated for dogs with MMVD or dilated cardiomyopathy that show signs of mild, moderate, or severe congestive heart failure, according to the company.²

The 2 drugs, which contain the same active ingredient at the same dose, will be marketed separately with unique application numbers and separate labels.¹

"We are thrilled to expand our pet therapeutic portfolio to include an option for dogs with asymptomatic canine valve disease," said Shawn Hooker, head of US Pet Business, Boehringer Ingelheim Animal Health, in an organizational release.² "We understand the importance in early treatment to delay the onset of symptoms related to heart failure to help dogs continue to engage in the daily activities they enjoy."

According to Boehringer Ingelheim,² a study containing client-owned dogs that were treated with pimobendane oral tablets showed a prolonged, symptom-free life for an average of 15 months compared to dogs treated with a placebo. Some notable adverse effects reported during the study were coughing, vomiting, lethargy, diarrhea, and localized pain. The oral pimobendane treatment was not tested in dogs with congenital heart defects, diabetes mellitus, or other serious metabolic diseases, nor in dogs younger than 6 months, and those pregnant, lactating, or used for breeding. Although MMVD occurs in many dog breeds, it occurs most often in smaller dogs such as Yorkshire terriers, cavalier King Charles spaniels, and dachshunds, according to the company.

Boehringer Ingelheim has 5 years to obtain full FDA approval for pimobendane oral tablets to delay the start of congestive heart failure in dogs or the company will no longer be allowed to market the product. In tandem with the FDA, Boehringer Ingelheim created a study protocol for a clinical trial that will take place in the United States with hopes it will provide substantial evidence on the effectiveness of the treatment to get full approval. In the meantime, pimobendane oral tablets will be available by prescription only.

References

1. FDA conditionally approves first drug to delay onset of congestive heart failure in dogs. FDA. June 21, 2022. Accessed June 21, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-conditionally-approves-first-drug-delay-onset-congestive-heart-failure-dogs
2. FDA grants Boehringer Ingelheim Animal Health conditional aapproval for VETMEDIN®-CA1 (pimobendan) to treat canine valvular disease for Stage B2. Boehringer Ingelheim Animal Health. June 21, 2022. Accessed June 21, 2022. https://prnmedia.prnewswire.com/news-releases/fda-grants-boehringer-ingelheim-animal-health-conditional-approval-for-vetmedin-ca1-pimobendan-to-treat-canine-valvular-disease-for-stage-b2-301570423.html