German biopharmaceutical company Boehringer Ingelheim announced on Monday that the US 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).

According to Boehringer Ingelheim, 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% of dogs in their lifetime. Dogs that are affected by MMVD or dilated cardiomyopathy (DCM) may progress to CHF, with the heart unable to effectively pump blood throughout the body.

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. 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. In a second study, 79% of dogs with Stage B2 preclinical MMVD were successfully treated with VETMEDIN for one year without developing CHF.