<div id="readability-page-1"><div> <div> <ul type="disc"> <li>Heart disease affects approximately 10 percent of dogs in their lifetime1</li> <li>VETMEDIN® (pimobendan) from Boehringer Ingelheim is the only medication approved to treat preclinical mitral valve disease in dogs </li> <li>An expansion of a conditional approval, the FDA authorization broadens the use of VETMEDIN® in dogs with heart disease</li> </ul> , /PRNewswire/ -- Boehringer Ingelheim, a global leader in animal health, today announced that the U.S. Food and Drug Administration (FDA) has approved VETMEDIN (pimobendan) Chewable Tablets and VETMEDIN Solution (pimobendan oral solution), for the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). VETMEDIN is the only medication approved to treat preclinical heart disease in dogs and extend their symptom-free life. Heart disease is common in dogs, affecting approximately 10 percent of dogs in their lifetime.1 Dogs that are affected by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM) may progress to CHF, with the heart unable to effectively pump blood throughout the body. &#34;Heart disease is most often present in dogs long before symptoms are visible, so the ability to treat dogs with VETMEDIN early, before the disease progresses to CHF, is incredibly significant and will help increase the survival time and quality of life in dogs,&#34; explained Daniel Watkins, Head of U.S. Pet at Boehringer Ingelheim. &#34;VETMEDIN has been helping dogs with heart disease for more than 25 years, and we are thrilled that this full additional approval will allow us to improve the lives of more dogs.&#34; The approval is an expansion of an FDA conditional approval in 2022 for this indication and marks the first FDA full approval of an animal drug indication that was initially conditionally approved. The full approval was based on two multi-site studies. In the EPIC study, VETMEDIN delayed the onset of CHF or cardiac-related death by 15.6 months in dogs with Stage B2 preclinical MMVD, compared to the control arm.2 In a second study, 79% of dogs with Stage B2 preclinical MMVD were successfully treated with VETMEDIN for one year without developing CHF. The approval adds an additional indication to those already included in the VETMEDIN label – the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or DCM, for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. Studies have shown that VETMEDIN can help improve the survival time and quality of life for dogs with CHF due to MMVD or DCM.3-5 VETMEDIN is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license. IMPORTANT SAFETY INFORMATION: The safety of VETMEDIN® (pimobendan) Chewable Tablets and VETMEDIN® Solution (pimobendan oral solution) has not been established in dogs with asymptomatic heart disease caused by etiologies other than MMVD or in CHF caused by etiologies other than MMVD or DCM. The most common non-cardiac adverse reactions reported in field studies, were poor appetite, lethargy, diarrhea, dyspnea, vomiting, musculoskeletal pain, and ataxia. For full prescribing information see package insert or visit www.VETMEDINclinic.com. About 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 www.boehringer-ingelheim.com/animal-health. About 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 that can improve and extend lives 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. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. References: 1 Keene, Bruce W et al. &#34;ACVIM consensus guidelines for the diagnosis and treatment of myxomatous mitral valve disease in dogs.&#34; Journal of Veterinary Internal Medicine vol. 33,3 (2019): 1127-1140. doi:10.1111/jvim.15488. 2 Boswood A, Häggström J, Gordon SG, et al. Effect of Pimobendan in Dogs with Preclinical Myxomatous Mitral Valve Disease and Cardiomegaly: The EPIC Study-A Randomized Clinical Trial. J Vet Intern Med. 2016 Nov;30(6):1765-1779. doi: 10.1111/jvim.14586. Epub 2016 Sep 28. 3 Haggstrom J et al , Effect of pimobendan or benazepril hydrochloride on survival times in dogs with congestive heart failure caused by naturally occurring myxomatous mitral valve disease: the QUEST Study, J Vet Intern Med. 2008; 22(5): 1124-1135. 4 Lombard, Christophe W et al. &#34;Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs.&#34; Journal of the American Animal Hospital Association vol. 42,4 (2006): 249-61. doi:10.5326/0420249. 5 Luis Fuentes V et al, A Double-blind, Randomized, Placebo-Controlled Study of Pimobendan in Dogs with Dilated Cardiomyopathy J Vet Intern Med. 2002;16: 255-261. SOURCE Boehringer Ingelheim Animal Health USA Inc. <img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE5Jk5ld3NJdGVtSWQ9Q0w2NjI2MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTkxNjEwUFJfTkVXU19VU1BSX19fX19DTDY2MjYw?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE5Jk5ld3NJdGVtSWQ9Q0w2NjI2MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTkxNjEwUFJfTkVXU19VU1BSX19fX19DTDY2MjYw"/></div> </div></div>

Boehringer Ingelheim announced that the FDA has approved VETMEDIN (pimobendan) for delaying the onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. This approval expands on a conditional approval from 2022 and is based on studies showing VETMEDIN can significantly extend symptom-free life in affected dogs. The drug has been used for over 25 years and aims to improve the quality of life for dogs with heart disease. Safety information indicates potential adverse reactions, and the drug is not established for other heart disease causes.

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16:10 ET
			
			
				FDA approves first drug to delay the onset of congestive heart failure in dogs

16:10 ET FDA approves first drug to delay the onset of congestive heart failure in dogs