FDA Grants Boehringer Ingelheim Animal Health Conditional Approval for VETMEDIN®-CA1 (pimobendan) to Treat Canine Valvular Disease for Stage B2

2022-06-21

合作First in Class

The drug demonstrated an average of 15 months of a prolonged, symptom-free life and is one of the first products granted conditional approval under the newly expanded FDA criteria

DULUTH, Ga., June 21, 2022 /PRNewswire/ --– Boehringer Ingelheim Animal Health announced today that the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) has granted conditional approval of VETMEDIN®-CA1 (pimobendan), which is indicated for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD), a form of chronic valvular heart disease in dogs. Based on a study, dogs treated with VETMEDIN-CA1 demonstrated an average of 15 months of a prolonged, symptom-free life compared to dogs treated with a placebo.

"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 U.S. Pet Business, Boehringer Ingelheim Animal Health. "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."

VETMEDIN-CA1 will be available by veterinary prescription in 1.25 mg and 5.0 mg chewable tablets beginning Q3 2022.

Please see additional Important Safety Information below.

About Canine Valvular Heart Disease

According to the American College of Veterinary Internal Medicine (ACVIM), MMVD is the most common heart disease of dogs in many parts of the world, accounting for approximately 75% of heart disease cases seen in dogs by veterinary practices in North America. It is estimated that approximately 10% of dogs presented to primary care veterinary practices have heart disease.

According to the 2019 ACVIM Consensus Statement, canine valvular heart disease for Stage B2 dogs refers to asymptomatic dogs which have met specific criteria, including a moderate or loud heart murmur and severely enlarged heart.

Treatment Options

VETMEDIN® (pimobendan) is approved for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to MMVD or dilated cardiomyopathy. VETMEDIN is indicated for use with concurrent therapy for congestive heart failure as appropriate on a case-by-case basis.

Now with the conditional approval of VETMEDIN-CA1, the drug has demonstrated a reasonable expectation of effectiveness in a field study to delay the onset of congestive heart failure in dogs with Stage B2 preclinical MMVD.

VETMEDIN and VETMEDIN-CA1 will be marketed separately with two separate labels, and each drug has a unique application number, New Animal Drug Application (NADA) 141-273 and 141-556 respectively.

Newly Expanded Approval Guidelines

VETMEDIN-CA1 is one of the first conditionally approved products under the newly expanded FDA criteria, which is granted for animal drugs to treat serious, life-threatening diseases for which there are no approved therapies available. Drug safety has been demonstrated for Vetmedin-CA1 and the drug is manufactured in accordance with full approval standards.

Moving forward, together with the FDA, Boehringer Ingelheim has developed a study protocol for a clinical trial to be conducted in the U.S. with the intention of providing substantial evidence of effectiveness as is required to gain full approval.

It is a violation of Federal law to use VETMEDIN-CA1 other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness.

IMPORTANT SAFETY INFORMATION

The most common side effects seen in dogs with Stage B2 MMVD while taking VETMEDIN-CA1 Chewable Tablets are cough, vomiting, diarrhea, lethargy (lack of energy), and localized pain (such as in the neck or legs).

VETMEDIN is only for use in dogs with clinical evidence of heart failure.

The safe use of VETMEDIN-CA1 has not been evaluated in dogs younger than 6 months of age, dogs with congenital heart defects, dogs with diabetes mellitus or other serious metabolic diseases, dogs used for breeding, or pregnant or lactating bitches.

About Boehringer Ingelheim Animal Health USA

Boehringer Ingelheim Animal Health is working on first-in-class innovation for the prediction, prevention, and treatment of diseases in animals. For veterinarians, pet owners, producers, and governments in more than 150 countries, we offer a large and innovative portfolio of products and services to improve the health and well-being of companion animals and livestock.

As a global leader in the animal health industry and as part of the family-owned Boehringer Ingelheim, we take a long-term perspective. The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too. By using the synergies between our Animal Health and Human Pharma businesses and by delivering value through innovation, we enhance the health and well-being of both.

Learn more about Boehringer Ingelheim Animal Health USA at https://bi-animalhealth.com/

VETMEDIN® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

SOURCE Boehringer Ingelheim