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News Article

FDA Approves New Drug for Heart Failure


First drug approved to treat congestive heart failure in dogs in USA, in over ten years.

The U.S. Food and Drug Administration (FDA) has announced the approval of Vetmedin (pimobendan) for the management of the signs of mild, moderate, or severe (modified New York Heart Association Class II, III, or IV) congestive heart failure in dogs due to atrioventricular valvular insufficiency or dilated cardiomyopathy. Vetmedin, a new molecular entity, is the first drug approved to treat congestive heart failure in dogs, in over ten years. Vetmedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

Vetmedin helps alleviate signs of heart failure by increasing contractility (the force of heart muscle contraction) and by dilating blood vessels (decreasing resistance to blood flow).

The effectiveness and safety of Vetmedin were evaluated in a 56-day, multi-site, active controlled field study with pivotal success determined at Day 29. Dogs (n=355) with modified New York Heart Association Class II, III, or IV congestive heart failure due to atrioventricular valvular insufficiency or dilated cardiomyopathy were randomly assigned to either the Vetmedin treatment group or the active control Enacard (enalapril maleate) treatment group. Treatment success at Day 29 in the Vetmedin group (80.7%) was determined to be non-inferior to the treatment success in the Enacard group (76.1%).

Adverse reactions associated with Vetmedin (and Enacard) were potentially related to congestive heart failure, the therapy of congestive heart failure, or both and included poor appetite, lethargy, diarrhea, worsening signs of heart failure, heart failure death, azotemia (increase in the blood urea nitrogen), and mild increases in serum liver enzymes.

Pimobendan is not for use in cats and is only for use in dogs with clinical evidence of heart failure due to atrioventricular valvular insufficiency or dilated cardiomyopathy. Pimobendan acts to alleviate the clinical signs of congestive heart failure, rather than to reverse the underlying cardiac pathology, and it does not replace the need for other appropriate concurrent heart failure therapy (diuretics, antiarrhythmic drugs, etc.).

Vetmedin is manufactured by MEDA Manufacturing GmbH, Cologne, Germany for Boehringer Ingelheim Vetmedica, Inc. of St. Joseph, Missouri.

For more information on Vetmedin, please see http://www.fda.gov/OHRMS/DOCKETS/98fr/2007-141-273-fois001.pdf.

Article details

  • Author(s)
  • R. Wood
  • Date
  • 22 May 2007
  • Source
  • FDA
  • Subject(s)
  • Veterinary medicine