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Oral Solution Approved By The FDA For Canine Heart Failure

Vetmedin Solution from Boehringer Ingelheim is indicated for treatment of cases caused by myxomatous mitral valve disease or dilated cardiomyopathy and is the first oral solution approved by the FDA for this use in dogs

Photo: Fukume/Adobe Stock

A new drug for the management of signs of congestive heart failure (CHF) in dogs has been approved by FDA officials. The drug, pimobendan oral solution (Vetmedin Solution; Boehringer Ingelheim [BI]), is indicated for treatment of CHF caused by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM) and is the first oral solution approved by the FDA for this use, according to a news release.1

Heart disease affects approximately 10% of dogs in their lifetime, and MMVD accounts for about 75% of these cases presented at veterinary practices in North America.2 Both MMVD and DCM may progress to CHF, according to BI.

The Vetmedin brand of pimobendan therapies has been on the market for 25 years. The product line includes Vetmedin Chewable Tablets for management of signs of mild, moderate or severe canine CHF caused by MMVD or DCM. These tablets and Vetmedin Solution are indicated for concurrent therapy use in treating CHF, on a case-by-case basis. Additionally, Vetmedin-CA1 may delay the onset of heart failure symptoms in dogs and is conditionally approved by the FDA for canines with stage B2 preclinical MMVD.1

"We continue to deliver new innovations rooted in robust clinical evidence to help more pets," Daniel Watkins, vice president of US Pet Business for Boehringer Ingelheim, said in the release.1 "We know some dogs and pet owners may prefer a liquid medication, especially for smaller dogs. With Vetmedin Solution, an easy-to-use liquid formulation, we can help more dogs with heart disease have longer survival and live better lives."

The safety and effectiveness of pimobendan oral solution for its indicated use was established by demonstrating the bioequivalence of Vetmedin Chewable Tablets.3 In dogs with MMVD or DCM, previous studies have demonstrated that pimobendan could help increase the survival time and quality of life.4,5

In a 2013 study comparing pimobendan vs benazepril hydrochloride on quality of life variables, 124 dogs were randomized to receive treatment. Although the incidence of arrhythmia was similar in both treatment groups, dogs administered pimobendan were shown to have smaller heart size, higher body temperature and less water retention.4

Another study, published in 2006, compared the clinical efficacy of pimobendan vs benazepril hydrochloride for acquired atrioventricular valvular disease in dogs. This randomized, positive-controlled, multicenter investigation enrolled 76 canines with clinical acquired atrioventricular valvular disease. The study found that dogs receiving pimobendan had a long-term median survival of 415 days vs 128 days for dogs that did not receive pimobendan.5

Adverse effects of pimobendan were reported in a clinical study prior to the approval of Vetmedin Chewable Tablets. In the 56-day study, common adverse effects in 175 dogs with CHF and MMVD or DCM receiving the Vetmedin tablets included poor appetite, lethargy, diarrhea, and dyspnea. Additionally, azotemia, weakness and atxia, pleural effusion, syncope, and cough were reported. In 6% of these studied dogs, sudden death was reported. The prevalence of adverse effects was similar in the study's active control group of 180 dogs receiving enalapril maleate.3

The safety of the pimobendan oral solution product has not been established in dogs with asymptomatic heart disease and heart failure caused by conditions other than MMVD or DCM. This product has also not been evaluated in dogs young than 6 months with congenital heart defects, those with diabetes or other serious metabolic diseases, or in dogs used for breeding, or are pregnant or lactating.3

References

Boehringer Ingelheim launches Vetmedin Solution (pimobendane oral solution), first oral solution approved by the FDA for congestive heart failure in dogs. News release. Boehringer Ingelheim. November 22, 2024. Accessed November 22, 2024. Https://www.Prnewswire.Com/news-releases/boehringer-ingelheim-launches-vetmedin-solution-pimobendan-oral-solution-first-oral-solution-approved-by-the-fda-for-congestive-heart-failure-in-dogs-302314386.Html?Tc=eml_cleartime

Keene BW, Atkins, CE, Bonagura JD, et al. ACVIM consensus guidelines for the diagnosis and treatment of myxomatous mitral valve disease in dogs. J Vet Intern Med. 2019;33(3):1127-1140. Doi:10.1111/jvim.15488

Vetmedin Solution. Product label. Boehringer Ingelheim. 2023. Accessed November 22, 2024. Https://docs.Boehringer-ingelheim.Com/VetmedinSolutionPI_2024.Pdf

Häggström J, Boswood A, O'Grady M, et al. Longitudinal analysis of quality of life, clinical, radiographic, echocardiographic, and laboratory variables in dogs with myxomatous mitral valve disease receiving pimobendan or benazepril: the QUEST study. J Vet Intern Med. 2013;27(6):1441-1451. Doi:10.1111/jvim.12181

Lombard, Christophe W et al. Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs. J Am Anim Hosp Assoc. 2006;42(4):249-61. Doi:10.5326/0420249

Boehringer Ingelheim Introduces US FDA Approved VETMEDIN Solution For Congestive Heart Failure In Dogs

Boehringer Ingelheim, a global leader in animal health, launched VETMEDIN Solution, the first oral solution approved by the US Food and Drug Administration (FDA) for the management of congestive heart failure (CHF) in dogs due to MMVD or DCM.

Unfortunately, heart disease in dogs is common, affecting approximately 10 percent of dogs in their lifetime. Most frequently, dogs are affected by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM), both which may progress to CHF, characterized by the inability of the heart to effectively pump blood throughout the body.

Now pet owners have a convenient, new management option to support the hearts of dogs with CHF: a liquid version of VETMEDIN, one of the leading canine cardiology medications in the world. Previous studies have shown that VETMEDIN could help increase the survival time and quality of life in dogs due to MMVD or DCM.

"We continue to deliver new innovations rooted in robust clinical evidence to help more pets," said Daniel Watkins, VP US Pet Business, Boehringer Ingelheim. "We know some dogs and pet owners may prefer a liquid medication, especially for smaller dogs. With VETMEDIN Solution, an easy-to-use liquid formulation, we can help more dogs with heart disease have longer survival and live better lives."

VETMEDIN Solution, now available in the US, provides the same dual mode of action as VETMEDIN chewable tablets. The flavourless, twice-daily liquid oral solution should be administered directly into the dog's mouth.

Since VETMEDIN was first introduced 25 years ago, dogs and their owners around the world have enjoyed more than 1 million years of additional life to love. VETMEDIN chewable tablets are approved for the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or DCM. VETMEDIN chewable tablets are indicated for use with concurrent therapy for congestive heart failure (e.G., furosemide, etc.) as appropriate on a case-by-case basis.

Boehringer Ingelheim also offers VETMEDIN-CA1 (pimobendan), which has FDA conditional approval for use in dogs with Stage B2 preclinical MMVD – which may enable a delay in the onset of heart failure symptoms.

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies in areas of high unmet medical need.

Boehringer Ingelheim Introduces VETMEDIN® Solution, A Liquid Treatment For Canine Heart Failure

Boehringer Ingelheim Introduces VETMEDIN® Solution, a Liquid Treatment for Canine Heart Failure

(IN BRIEF) Boehringer Ingelheim has launched VETMEDIN® Solution, the first FDA-approved liquid treatment for congestive heart failure (CHF) in dogs caused by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). The solution provides a convenient, twice-daily alternative to tablets, ideal for smaller dogs or those who prefer liquid medication. Backed by clinical studies, VETMEDIN® improves survival times and quality of life for dogs with CHF. This launch adds to Boehringer Ingelheim's legacy of advancing animal health, with VETMEDIN® already helping dogs enjoy over 1 million additional years of life.

(PRESS RELEASE) INGELHEIM, 27-Nov-2024 — /EuropaWire/ — Boehringer Ingelheim, a global leader in animal health, has launched VETMEDIN® Solution, the first FDA-approved oral liquid solution for managing congestive heart failure (CHF) in dogs caused by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Heart disease affects approximately 10% of dogs during their lifetime, with MMVD and DCM being the most common causes of CHF.

This new liquid formulation provides pet owners with a convenient alternative to VETMEDIN® Chewable Tablets, offering the same dual mode of action to support heart health in dogs. The flavorless solution is administered twice daily directly into a dog's mouth, making it an ideal option for smaller dogs or those who struggle with tablets.

Backed by Clinical Evidence

Studies have demonstrated that VETMEDIN® significantly improves survival times and quality of life for dogs suffering from CHF due to MMVD or DCM. "We are committed to delivering innovations that help pets live longer, healthier lives," said Daniel Watkins, Vice President of Boehringer Ingelheim's US Pet Business. "VETMEDIN® Solution gives pet owners another way to manage their dog's heart disease effectively."

A Legacy of Heart Health Support

For 25 years, VETMEDIN® has been a cornerstone of canine cardiology, helping dogs and their families enjoy more than 1 million additional years of life together. Boehringer Ingelheim also offers VETMEDIN®-CA1 (pimobendan), conditionally approved by the FDA for Stage B2 preclinical MMVD, which may delay the onset of heart failure symptoms.

The launch of VETMEDIN® Solution marks another milestone in Boehringer Ingelheim's mission to advance animal health through innovative, evidence-based treatments. For more information, visit www.Boehringer-ingelheim.Com/animal-health.

Boehringer Ingelheim – Animal Health business

Boehringer Ingelheim provides innovation for preventing and treating diseases in animals. The company offers a wide range of vaccines, parasite-control products, and medicines for pets, horses, and livestock to veterinarians, animal owners, farmers, and governments. As a leader in animal health, Boehringer Ingelheim values that the health of humans and animals is deeply connected and strives to make a difference for people, animals, and society. Learn more at https://www.Boehringer-ingelheim.Com/animal-health.

Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at https://www.Boehringer-ingelheim.Com/.

Intended Audiences Notice

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

1 Keene, Bruce W et al. "ACVIM consensus guidelines for the diagnosis and treatment of myxomatous mitral valve disease in dogs." Journal of Veterinary Internal Medicine vol. 33,3 (2019): 1127-1140. Doi:10.1111/jvim.15488

2 Häggström, J et al. "Longitudinal analysis of quality of life, clinical, radiographic, echocardiographic, and laboratory variables in dogs with myxomatous mitral valve disease receiving pimobendan or benazepril: the QUEST study." Journal of Veterinary Internal Medicine vol. 27,6 (2013): 1441-51. Doi:10.1111/jvim.12181

3 Lombard, Christophe W et al. "Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs." Journal of the American Animal Hospital Association vol. 42,4 (2006): 249-61. Doi:10.5326/0420249

4 Epidemiologic simulation of Vetmedin usage 1999-2024, based on EPIC 2016 JVIM (MMVD, stage B2), QUEST 2008 JVIM (MMVD, stage C), PROTECT 2012 JVIM (DCM, stage B2), O`Grady 2008 JVIM (DCM, stage C), Fuentes 2002 JVIM (DCM stage C) and BI-owned sales data.

Media Contact:

Mi-Kyung Lee-LangeAnimal Health Communications Leademail: mi-kyung.Lee-lange@boehringer-ingelheim.Com

SOURCE: Boehringer Ingelheim

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