Loyal, a biotech company working on a drug to extend dogs’ lifespan, has received its first stamp of approval for their longevity drug for dogs from The Food and Drug Administration (FDA) on Tuesday, November 28.
Business Wire reports that FDA’s Center for Veterinary Medicine has approved the Reasonable Expectation of Effectiveness section of Loyal’s conditional approval application for the new drug.
FDA’s conditional approval helps “ensure that innovative treatments are available for small populations of animals and species that have few drugs approved for them.”
However, conditional approvals are different from full approvals as they only last for up to five years.
And for a full approval, the company must provide FDA with substantial evidence of the the drug’s effectiveness.
But Loyal’s conditional approval on this new drug is considered a milestone in treating age-related diseases in animals and ensuring more healthy years for our furry friends.
Loyal CEO Celine Halioua wrote in a post, “Today, I’m so proud to announce that Loyal has earned what we believe to be the FDA’s first-ever formal acceptance that a drug can be developed and approved to extend lifespan.”
She explained, “In regulatory parlance, we have completed the technical effectiveness portion of our conditional approval application for LOY-001’s use in large dog lifespan extension.”
As we all know, large dog breeds have a significantly shorter lifespan than small and medium-sized breeds.
And with the longevity drug, code name LOY-001, large dog breeds will be able to enjoy a longer lifespan while maintaining their quality of life as they age.
Halioua reveals how LOY-001 can help extend a dog’s lifespan. She explains that the drug will reduce the levels of the hormone that drives cell growth, called IGF-1, in large dog breeds to levels seen in small or medium-sized breeds.
This is because breeding for size causes dogs to have highly elevated levels of IGF-1.
And this hormone is a double-edged sword — high levels of it effectively accelerates a dog’s growth when they’re puppies. But the same levels in adult dogs speeds up their aging, which in turn, reduces their healthy lifespan.
LOY-001 is designed as an injectable administered by veterinarians every three to six months. And according to Loyal, will be available in 2026 (subject to FDA approval of Loyal’s manufacturing and safety data).
Halioua said, “Four years ago I founded Loyal with a simple vision — to bring to market the first drug explicitly approved and labeled for healthy lifespan extension.”
“Loyal was only a few months old and about five people when we decided to begin by targeting the abnormally short lifespan of large breed dogs with a drug program we code-named LOY-001,” she continued.