Loyal, a biotech company focused on developing a drug to increase the lifespan of dogs, has achieved its first approval from the Food and Drug Administration (FDA) for their longevity drug for dogs on November 28.
According to Business Wire, the FDA’s Center for Veterinary Medicine has approved the Reasonable Expectation of Effectiveness section of Loyal’s conditional approval application for the new drug.
Conditional approvals from the FDA are crucial in making innovative treatments available for animals with few approved drugs. However, these approvals only last for a maximum of five years.
In order to obtain full approval, the company must provide substantial evidence of the drug’s effectiveness. Nonetheless, Loyal’s conditional approval marks a significant milestone in the treatment of age-related diseases in animals, offering more healthy years for our beloved pets.
Loyal’s CEO, Celine Halioua, expressed her pride in the company’s achievement, stating, “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 further explained, “In regulatory terms, we have completed the technical effectiveness portion of our conditional approval application for LOY-001’s use in large dog lifespan extension.”
Large dog breeds typically have a shorter lifespan compared to smaller breeds. With the introduction of the longevity drug, known as LOY-001, large dog breeds can potentially live longer while maintaining their quality of life as they age.
Halioua elaborated on how LOY-001 works to extend a dog’s lifespan by reducing levels of the hormone IGF-1, which drives cell growth, to levels observed in smaller breeds. Breeding for size often results in elevated levels of IGF-1 in dogs, which accelerates growth during puppyhood but speeds up aging in adult dogs, decreasing their healthy lifespan.
LOY-001 is designed as an injectable that veterinarians can administer every three to six months. Loyal anticipates that the drug will be available in 2026 pending FDA approval of the company’s manufacturing and safety data.
Halioua shared, “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.”
She added, “Loyal was only a few months old and consisted of about five people when we decided to focus on addressing the abnormally short lifespan of large breed dogs with a drug program we called LOY-001.”