As any dog lover will tell you, the worst thing about owning a dog is that man's best friend just doesn't live long enough, especially if your friend is a large breed.
Well, a San Francisco biotech company, Loyal, is trying to change that, and the US Food and Drug Administration (FDA) is one step closer to allowing them to carry their life-extending drug market life
“There are 25 million large breed dogs in the United States alone, which means 25 million dogs that we can help live longer and with a better quality of life,” said Loyal CEO and Founder Celine Halioua . Fox News Digital in a statement.
If your dog weighs more than 40 pounds, the drug LOY-001 could help slow age-related processes, according to the company. It would be the first animal drug of its kind approved or conditionally approved by the FDA.
According to Fox News Digital, “The drug works by interacting with a hormone called IGF-1 that speeds up the aging process.”
Rather than waiting for the symptoms of aging to appear, age-related canine diseases can be prevented, a Loyal spokesperson said.
(Video: Fox News)
According to the company web site, “Large and giant breed dogs have an average life expectancy that is only half that of smaller breeds. LOY-001 targets the biological mechanisms thought to cause this life disparity.”
The medication is long-acting and must be given to your dog by your vet 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 is the first formal acceptance by the FDA that a life-extending drug can be developed and approved.”
“In regulatory language,” Loyal's founder said, “we have completed the technical efficacy portion of our application for conditional approval for the use of LOY-001 in extending the shelf life of big dogs.”
“Because there was no established regulatory pathway for a shelf-life extension drug, we had to design from scratch a scientifically strong and logistically feasible way to demonstrate the efficacy of an aging drug,” he explained Halliow “This process took more than four years, resulting in the more than 2,300-page technical section now approved by the FDA. It included intervention studies of LOY-001 in an FDA-accepted canine aging model and a observational study (without medication) of 451 dogs”.
“Based on our data, the FDA believes that LOY-001 is likely to be effective for life extension in older dogs in the real world,” he said.
There are still more FDA hurdles to clear, however, “Once we satisfactorily complete the safety and manufacturing sections and other requirements, veterinarians will be able to prescribe LOY-001 to extend the lifespan of older dogs while we complete the study parallel fundamental life extension,” Halioua said.
A clinical study is underway and interested pet owners can go to the website for more information as it becomes available. If all goes well, the drug is expected to be launched in 2026.
For now, Halioua said, the FDA's gesture toward LOY-001 is an important milestone.
“Each milestone we've reached in this methodical, evidence-based process has demonstrated steady progress toward our vision of helping dogs live longer and stay healthy as they age,” he wrote. “This is especially important because it marks a key step toward FDA approval based on credible, carefully reviewed data.”
Veterinarians.org veterinarian Dr. Ivana Crnec called LOY-001 “groundbreaking.”
“In my professional opinion, the drug is groundbreaking,” Crnec told Fox News Digital. “We still have to wait and see its results and potential side effects, but so far, LOY-001 is definitely showing promise. The fact that the FDA describes the drug as having 'reasonable expectations of efficacy' speaks volumes for its potential “.
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