Biotechnology company Loyal has reached a milestone that could prove key on the path to approval of its drug to extend the life of large breed dogs.The Center for Veterinary Medicine of the US Food and Drug Administration (FDA) confirmed that the data provided in a report of more than 2,000 pages by the San Francisco firm meets the requirements to request accelerated conditional approval of the entity for animal therapies.
That means that the FDA endorses that the drug developed by Loyal has “a reasonable expectation of effectiveness” or, in other words, that the FDA believes that the drug (called LOY-001), is “probably effective” in increasing life of the big dogs.
Large dogs, breeds like golden retrievers, Great Danes, or Newfoundlands, tend to have noticeably shorter lifespans than small breed dogs. While the latter can live 12 or 13 years, the average life expectancy of large dogs is eight to 10 years. Studies suggest this may be due to an unintended effect of decades of selective breeding.
Herding, protection and companionship
“The extreme phenotypic variety found in dogs is not ‘natural’, it is the result of intensive breeding by humans to create dogs that excelled at tasks such as herding, protection and companionship. “We see the short lifespan of large dogs not as inevitable, but as a disease caused by historical artificial selection and therefore amenable to targeting and treatment with a drug.” –Brennen McKenzie, Director of Veterinary Medicine at Loyal.
How does the medicine work?
Loyal is still required to provide authorities with safety and manufacturing data for LOY-001. But if conditional approval is granted, the drug could begin to be marketed, even pending full approval. As things stand, it could begin to be sold in 2026.
LOY-001 works by acting on the growth hormone IGF-1, which is believed to be present at elevated levels in large dogs. Designed to be injected every three to six months, the drug reduces the presence of IGF-1 to levels commonly seen in smaller dogs. Loyal says that would be enough to prolong the animal’s life by five or more years.
By slowing aging, the drug not only offers hope that dogs may live a little longer, but, in the process, that they will enjoy a better quality of life as they age. It may also mark an important step in the development of longevity drugs in general.
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