Drug designed to extend dogs' lives takes major step toward FDA approval
A drug that could extend large dogs' lifespans and help keep them healthier as they age is one step closer to coming to the market.
Why it matters: Bigger dogs live shorter lives than smaller dogs "by nearly half," notes a statement from Loyal for Dogs, which announced Tuesday that the drug it's developing, LOY-001, had cleared a key FDA regulatory hurdle required in the approval process.
Driving the news: The San Francisco-based biotech company said the experimental drug that still has to undergo clinical trials had met the "reasonable expectation of effectiveness" section requirement for the FDA's expanded conditional approval — "an accelerated pathway for animal drugs that aims to increase the availability of innovative therapies."
- A U.S. Food and Drug Administration official said in a letter that Loyal shared with the New York Times: "The data you provided are sufficient to show that there is a reasonable expectation of effectiveness."
Context: The average lifespan for larger dogs is about 8 to 12 years, per the American Kennel Club. Bernese mountain dogs' and Great Danes' life expectancy is 7-10 years and 8-10 years, respectively, the AKC notes.
- For small breeds, the average is 10 to 15 years — though Chihuahuas can live for up to 20 years.
Zoom in: The veterinarian-administered drug is designed to be a long-acting product given to large- and giant-breed dogs every three to six months, according to Loyal.
- The FDA based its decision on data Loyal submitted that included studies showing LOY-001's ability to reduce levels of key growth hormone insulin growth factor-1 (IGF-1) "and the beneficial impact on functional outcomes in dogs," according to the company.
- "This was further supported by a large observational study of the functional and biomarker impacts of canine aging. The study involved 452 companion dogs of 84 different breeds, aged two to 18. It validated the clinical relevance of the functional outcomes seen in Loyal's earlier studies."
What we're watching: Loyal hopes to gain FDA approval by 2026.
- "We're going to be going for claiming at least one year of healthy life span extension," said Celine Halioua, the founder and CEO of Loyal, to the NYT.
Between the lines: Danika Bannasch, a veterinary geneticist at the University of California, Davis, who was involved in a study published last month that found the gene ERBB4 could be a factor in dog longevity, told Wired IGF-1 was one believed driver of dog size and lifespan.
- "As for targeting it, I think it's a bit premature. We know that smaller breed dogs live longer than larger breed dogs, but we don't know how much of that is due to the influence of IGF-1," she added.
The bottom line: Halioua told Axios San Francisco in August: "We're not making immortal dogs, to be clear, but that rate of aging will be slower, hopefully, which means the pet will be in a healthier state for longer. And that's fundamental to all of the biology of what we're doing."