FDA close to approving ‘groundbreaking’ drug that could prolong your dog’s life

As any dog lover will tell you, the worst thing about owning a pooch is that Man’s Best Friend simply doesn’t live long enough — especially if your buddy is a large breed.

Well, a San Francisco biotech company — Loyal — is trying to change that, and the U.S. Food and Drug Administration (FDA) is a step closer to allowing them to bring their life-extending drug to market.

“There are 25 million large-breed dogs in the U.S. alone — that’s 25 million dogs we can help live longer, and with better quality of life,” Loyal’s CEO and founder Celine Halioua told Fox News Digital in a statement.

If your dog weighs more than 40 pounds, the drug LOY-001 could help to slow down age-related processes, according to the company. It would be the first such animal drug to be approved or conditionally approved by the FDA.

According to Fox News Digital, “The medication works by interacting with a hormone called IGF-1 that accelerates the aging process.”

Rather than wait for the symptoms of aging to appear, age-related canine diseases can be prevented, a spokesperson for Loyal said.

(Video: Fox News)

According to the company’s website, “Large and giant breed dogs have average life expectancies that are only half that of the smallest breeds. LOY-001 targets the biological mechanisms thought to cause this lifespan disparity.”

The drug is long-acting and is to be administered to your dog by their veterinarian every three to six months.

“Loyal’s approach represents a different paradigm, using our understanding of the underlying mechanisms of aging to reduce the risk of these diseases in the first place,” the company told Fox News Digital in a statement.

At the end of November, Halioua announced that the drug had received “what we believe to be the FDA’s first-ever formal acceptance that a drug can be developed and approved to extend lifespan.”

“In regulatory parlance,” Loyal’s founder said, “we have completed the technical effectiveness portion of our conditional approval application for LOY-001’s use in large dog lifespan extension.”

“As there was no established regulatory path for a lifespan extension drug, we had to design from scratch a scientifically strong and logistically feasible way to demonstrate efficacy of an aging drug,” Halioua explained. “This process took more than four years, resulting in the 2,300+ page technical section now approved by the FDA. It included interventional studies of LOY-001 in an FDA-accepted model of canine aging and an observational (no-drug) study of 451 dogs.”

“From our data, the FDA believes LOY-001 is likely to be effective for large dog lifespan extension in the real world,” she stated.

There are still more FDA hurdles to clear, but, “Once we satisfactorily complete safety and manufacturing sections and other requirements, vets will be able to prescribe LOY-001 to extend the lifespan of large dogs while we complete the confirmatory pivotal lifespan extension study in parallel,” Halioua said.

A clinical study is upcoming, and interested pet owners can go to the website to receive more information as it becomes available. If all goes well, the drug is expected to launch in 2026.

For now, Halioua said, the FDA’s nod towards LOY-001 is an important milestone.

“Each milestone we’ve achieved in this methodical, evidence-based process has demonstrated steady progress toward our vision of helping dogs live longer and stay healthy as they age,” she wrote. “This one is especially important because it marks a key step toward FDA approval based on credible, carefully reviewed data.”

Dr. Ivana Crnec, a veterinarian with Veterinarians.org, called LOY-001 “groundbreaking.”

“In my professional opinion, the drug is groundbreaking,” Crnec told Fox News Digital. “We still need to wait and see its results and potential side effects, but so far, LOY-001 is definitely promising. The fact that the FDA described the drug as having ‘reasonable expectations of effectiveness’ says a lot about its potential.”

Melissa Fine


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