Life-Extending Drug For Senior Dogs Reaches Key FDA Approval Milestone

Watching dogs grow and get older is a bittersweet experience, but what if there was a way we could give our canine companions longer, healthier lives? Well, that reality just came one step closer, with an announcement from biotech company Loyal that its lifespan-extending drug for senior dogs has reached a key milestone towards Food and Drug Administration (FDA) approval.

According to a February 26 press release, the FDA’s Center for Veterinary Medicine found that the drug, named LOY-002, meets a condition known as “reasonable expectation of effectiveness” (RXE).

This means that Loyal’s data suggests that LOY-002 is reasonably likely to do what it says on the tin – extend the lifespan of dogs that are 10 years and older and help them maintain a healthy quality of life whilst doing so. 

The drug works by mimicking calorie restriction, which has previously been shown to affect lifespan and health. Anyone who’s owned a dog knows that they aren’t exactly fans of diets, so being able to give them a pill every day instead presents a much more practical option – although let’s be honest, it’s not going to stop them giving you puppy eyes whenever you go near the treat cupboard.

Meeting the RXE condition is a key step in an FDA pathway known as expanded conditional approval, which allows companies to market a drug – and vets to prescribe it – while giving them five years to gather additional research demonstrating the efficacy of the drug, after which it might earn full FDA approval.

There are still two requirements that Loyal must meet to get expanded conditional approval: demonstrating that LOY-002 is safe, and that its manufacturing is high-quality when scaled up. Achieving that could come sooner rather than later.

“We have extensive data supporting both and hope to have completed all the regulatory requirements by the end of 2025, making an FDA-approved longevity drug a reality for millions of dogs in the next year,” wrote Celine Halioua, Loyal’s CEO, in a blog post about the recent achievement.

This latest FDA milestone isn’t Loyal’s first; back in 2023, the company also demonstrated RXE for its drug LOY-001, designed specifically to extend the lifespan of big dog breeds. This is thought to have been the first time any lifespan-extending drug for any animal had reached this milestone.

“I’m extremely proud of that milestone,” Halioua told IFLScience. “It was a really, really big deal.”

Halioua hopes that if approved, the company’s drugs will not just extend lifespan, but the joy that both dogs and humans experience.

“The way I think about ageing drugs is kind of increasing free will,” said Halioua. “So, I want to help people have more years where they’re able to do the things that they want to do with their dogs.”

“In my case it’s taking [my dog] Della to the beach and running around with her. For others it might be trail running or just having them with their family and I’m kind of hoping we create that opportunity.”

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