An anti-aging drug that has the potential to extend the life of large-breed dogs is one step closer to being approved by the U.S. Food and Drug Administration (FDA). The company behind the anti-aging drug is San Francisco-based biotech company Loyal.
The drug, named LOY-001, has already made significant progress in gaining its much-needed approval by the FDA. By receiving the first of three green lights last Tuesday, it shows the promise of the effectiveness of the drug.
Following this development last week, the company announced, “Today’s milestone is a crucial part of Loyal’s application for conditional approval.”
In this news release, Loyal explained the significance of the step as “it means the FDA agrees LOY-001 has a reasonable expectation of effectiveness.”
They continued, “Once the FDA approves Loyal’s manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population.”
What is LOY-001, and is it effective?
According to Loyal’s claim, the drug intends to help slow down age-related processes in larger breeds of dogs. By interacting with a hormone called IGF-1, it targets the acceleration of the aging process in canines. The hormone is found in higher doses among larger dogs when compared to smaller breeds
A spokesperson for Loyal explained that the drug is designed to prevent canine diseases which are age-related.
“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,” a spokesperson for the company said.
So far, the four-year process of the drug has included interventional studies of LOY-001 and an observational study of 451 dogs, according to the company’s website.
What do doctors think of the drug?
Speaking to Fox News Digital, veterinarians explained that an average dog’s lifespan is approximately 10 to 13 years. The larger dogs, which LOY-001 hopes to help, age faster and have a shorter life expectancy.
Dr Ivana Crnec, veterinarian in association Veterinarians.org, made a link between body size and growth rate as key factors in affecting a dog’s longevity. When asked specifically about LOY-001, Crnec told Fox News Digital that, “In my professional opinion, the drug is groundbreaking.”
“We still need to wait and see its results and potential side effects, but so far, LOY-001 is definitely promising,” Crnec continued.
“The fact that the FDA described the drug as having ‘reasonable expectations of effectiveness’ says a lot about its potential.” (Dr Crnec was not involved in the research conducted.)
Other veterinarians seem cautiously optimistic in their support for the drug, with this first step in approval affirming this.
FDA approval will come from the completion of large clinical trials and a review of safety and manufacturing data. These are the next steps required for the company at this time. According to their website, their mission is “developing drugs intended to help dogs live long, healthier lives.”
No conditionally nor FDA-approved drugs are currently on the market for the purpose Loyal is advertising. Conditional approval lasts up to five years, and Loyal intends to utilize this time. By collecting the remaining evidence needed to apply for full approval, the drug is expected to be available by 2026.
