FDA Grants Boehringer Ingelheim Animal Health Conditional Approval for VETMEDIN®-CA1 (Pimobendan) for the Treatment of Canine Valvular Disease Stage B2
The drug has demonstrated an average of 15 months of prolonged, symptom-free life and is one of the first products to gain conditional approval under the FDA’s newly expanded criteria.
DULUTH, Ga., June 21, 2022 /PRNewswire/ –– Boehringer Ingelheim Animal Health today announced that the United States Center for Veterinary Medicine (FDA-CVM) has granted conditional approval to VETMEDIN®-CA1 (pimobendan), which is indicated for delaying the onset of congestive heart failure in dogs with preclinical myxomatous mitral valve disease (MMVD) stage B2, a form of chronic valvulopathy in dogs. Based on one study, dogs treated with VETMEDIN-CA1 demonstrated an average of 15 months of prolonged, symptom-free life compared to dogs treated with a placebo.
“We are excited to expand our companion animal therapy portfolio to include an option for dogs with asymptomatic canine valve disease,” said Shawn Hooker, Head of US Companion Animal Business, Boehringer Ingelheim Animal Health. “We understand the importance of 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 from the third quarter of 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 in dogs in many parts of the world, accounting for approximately 75% of cases of heart disease 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 ACVIM 2019 consensus statement, canine valvular heart disease in dogs stage B2 refers to asymptomatic dogs that have met specific criteria, including a moderate or loud heart murmur and severe cardiac enlargement.
VETMEDIN® (pimobendan) is approved for the management of signs of mild, moderate or severe congestive heart failure in dogs due to MMVD or dilated cardiomyopathy. VETMEDIN is indicated for use with concomitant treatment of congestive heart failure, as appropriate on a case-by-case basis.
Now, with conditional approval of VETMEDIN-CA1, the drug has demonstrated a reasonable expectation of efficacy in a field study in delaying the onset of congestive heart failure in dogs with preclinical stage B2 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 FDA’s newly expanded criteria, which are granted to veterinary drugs to treat serious and life-threatening conditions for which there are no approved therapies available. Drug safety has been demonstrated for Vetmedin-CA1 and the drug is manufactured under full approval standards.
Moving forward, in collaboration with the FDA, Boehringer Ingelheim has developed a study protocol for a clinical trial to be conducted in the United States with the intention of providing substantial evidence of efficacy as needed. to get full approval.
It is a violation of federal law to use VETMEDIN-CA1 other than as directed on the label. Conditionally approved by the FDA pending full demonstration of efficacy.
IMPORTANT SAFETY INFORMATION
- The most common side effects seen in dogs with stage B2 MMVD when taking VETMEDIN-CA1 chewable tablets are coughing, vomiting, diarrhea, lethargy (lack of energy), and localized pain ( as in the neck or legs).
- VETMEDIN should only be used in dogs showing clinical signs of heart failure.
- The safe use of VETMEDIN-CA1 has not been evaluated in dogs under 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 female dogs.
About Boehringer Ingelheim Animal Health UNITED STATES
Boehringer Ingelheim Animal Health is working on breakthrough innovation for the prediction, prevention and treatment of disease in animals. For veterinarians, pet owners, producers and governments in over 150 countries, we offer a broad, innovative portfolio of products and services to improve the health and well-being of pets and livestock. .
As a global leader in the animal health industry and part of the family business Boehringer Ingelheim, we take a long-term view. The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are also healthier. By utilizing the synergies between our Animal Health and Human Pharma businesses and delivering value through innovation, we improve the health and well-being of both.
Learn more about Boehringer Ingelheim Animal Health UNITED STATES at https://bi-animalhealth.com/
VETMEDIN® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.
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