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Loyal, a veterinary medicine company, aims to extend the healthspan and lifespan of dogs through the development of groundbreaking drugs. The company has received protocol concurrence from the FDA for its companion dog longevity study.
Loyal's mission is to help dogs live longer, healthier lives by developing the first FDA-approved drugs designed explicitly for this purpose.
As part of their path to FDA approval, Loyal must conduct a clinical trial that demonstrates the drug's effectiveness in extending dogs' healthy lifespan safely.
Since no one has developed a dog or human longevity drug before, Loyal is building the path to FDA approval largely from scratch.
A milestone in veterinary medicine and drug development
Karen Greenwood, Loyal's Senior Vice President, Regulatory & Strategy, says:
"This is a huge milestone for any drug company, but it's especially significant because, to our knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and healthspan, rather than only proving efficacy against a single, specific disease – which is the case with most drugs on the market today."
Still much work to be done
Despite the milestone, there is still much work to be done, as clinical trials are complex.
Researchers must make evidence-based decisions in study design and treatments, but the true performance of a drug in real-world settings won't be known until the study is conducted.
Greenwood emphasizes the importance of clinical trials, stating:
"If the study doesn't deliver a positive outcome, we won't – and shouldn't – get approval."
While supplements are not subject to the same rigorous FDA approval process, Loyal has chosen to pursue drug development due to the exacting standards applied to drug approval.
Greenwood explains that supplements do not guarantee safety or effectiveness, which is not sufficient, especially when it comes to our pets.