With the Reasonable Expectation of Effectiveness (RXE) and TAS sections now complete, LOY-002 has earned FDA-acceptance for two of three major technical sections required for market launch. Photo courtesy Loyal Loyal, a clinical-stage animal health company developing lifespan extension drugs for dogs, announced the U.S. Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) has accepted the Target Animal Safety (TAS) technical section of its conditional approval application for LOY-002, the company’s lead program to extend the healthy lifespan of senior dogs. With both the Reasonable Expectation of Effectiveness (RXE) and TAS sections now accepted, LOY-002 has reportedly completed two of the three major technical sections required for market launch. “Since founding Loyal six years ago, my goal has always been to get the first drug FDA approved for lifespan extension. This safety acceptance brings us very close to achieving that vision,” says Loyal founder and CEO Celine Halioua. “We are well on our way to bringing the first dog longevity drugs to market.” LOY-002 is a prescription daily pill designed to maintain quality of life in senior dogs by targeting metabolic drivers of aging and delaying disease onset. The FDA’s acceptance of TAS marks the first known safety approval for a lifespan extension drug in any species. The TAS submission included standard safety studies and field data from over 400 dogs in the pivotal STAY trial. As part of the TAS package, Loyal submitted scientific evidence from multiple studies to support LOY-002’s safety profile. Photo courtesy Loyal “As a veterinarian, what I care about most, especially when it involves preventive care, is safety,” says Dr. Ellen Ratcliff, Loyal’s VP of Clinical and Veterinary Medicine. LOY-002’s final technical section for FDA Expanded Conditional Approval is expected next year. For more information, visit the Loyal website.
