Jan 19 (Reuters) – Pharmaceutical company Boehringer Ingelheim said on Monday the U.S. Food and Drug Administration had approved its chewable tablet, as the first drug to delay congestive heart failure in dogs with a type of early-stage heart disease.
The approval covers dogs with a heart condition, known as myxomatous mitral valve disease, who show signs of heart enlargement but do not yet have symptoms.
The FDA said Vetmedin can now be used to slow the progression of the disease before dogs develop heart failure.
Vetmedin was first given conditional approval for this use in 2022, allowing it to be sold while the company collected more data. After three years of additional studies, Boehringer Ingelheim provided enough evidence for the FDA to grant full approval.
This marks the first time the FDA has fully approved a drug for animals after initially granting conditional approval under expanded rules designed to encourage new treatments for serious conditions.
Heart disease is common in dogs, affecting about 10 percent of dogs in their lifetime, the company said.
In a study, Vetmedin delayed the onset of congestive-heart-failure or cardiac-related death by 15.6 months.
(Reporting by Sahil Pandey and Katha Kalia in Bengaluru; Editing by Alistair Bell)
