The US Food and Drug Administration (FDA) has granted key approval for a drug that could extend the lives of large and giant-breed dogs. The drug, LOY-001, is being developed by Loyal, a biotechnology company based in San Francisco. The FDA has approved the Reasonable Expectation of Effectiveness section of Loyal's application for conditional approval. This means that the FDA believes that LOY-001 is likely to be effective in extending the lifespan of large and giant-breed dogs.
According to a letter disclosed by Loyal to the New York Times, a representative from the US Food and Drug Administration stated, "The data you provided are sufficient to show that there is a reasonable expectation of effectiveness."
On average, larger dogs generally have a lifespan of approximately 8 to 12 years, according to information from the American Kennel Club. Specifically, Bernese Mountain Dogs have a life expectancy of 7-10 years, while Great Danes typically live around 8-10 years.
Loyal has outlined that the veterinarian-administered medication is crafted to be a sustained-release product administered to large- and giant-breed dogs at intervals of three to six months.
According to Newsweek, while Loyal did not specify in the statement how long the drug could extend the lives of large canine companions, the company says on its website that the drug will be a "long-acting injectable" administered by a veterinarian every three to six months. At the time of publication, the estimated cost of the drug had not been released.
The FDA's expanded conditional approval is an "accelerated pathway" for the drug, which Loyal estimates will be available in 2026, Loyal spokesman Tim Smith said in a statement.
