A Life-Extension Drug for Big Dogs Is Getting Closer to Reality
Description
(Source: WIRED) The FDA has yet to approve any drugs for life extension. But biotech company Loyal is now a step closer to bringing one to market for dogs.
Loyal's drug, called LOY-001, is an injection-based treatment that targets a growth and metabolism hormone called IGF-1. This hormone seems to be size-related. it appears in higher levels in larger dogs and in lower levels in smaller dogs.
(Source: wired) There is a well-established inverse relationship between a dog's size and its expected lifespan. Bernese mountain dogs and Great Danes live just six to eight years, for example, while corgis can live up to 15 years and Chihuahuas up to two decades.
San Francisco biotech company Loyal wants to close that gap, and is developing an experimental drug to extend the lifespan and improve the quality of life of large and giant dog breeds. Today, the company announced that based on early data, the US Food and Drug Administration has determined that Loyals drug has a reasonable expectation of effectiveness. The company hasnt yet shown that its drug actually extends lifespan, but the FDA decision signals the agency's confidence in Loyal's approach, and the drug will soon be tested in a bigger trial.
The Conditional Approval Pathway
NOTE:
The FDA's Expanded Conditional Approval is an accelerated pathway for animal drugs that aims to increase the availability of innovative therapies. Its designed for drugs that demonstrate a reasonable expectation of effectiveness in addressing an unmet medical need, but require complex and difficult studies to complete collection of definitive effectiveness data.
Today's milestone is a crucial part of Loyal's application for conditional approval. It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness and, once the FDA approves Loyals manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population. Conditional approval lasts for up to five years, during which time Loyal will collect the remaining effectiveness data and apply for full approval.
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| Journal Topics | Pets Health & Wellness |
| Journal Types | Contains: Links & URLs, Contains: Videos , Information |
| Medical Services | Advanced medical treatments |
| Source Verified: Health News Organizations | FDA Conditional, Wired |
| Veterinarian Care & Therapy | Wellness Care |
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