FDA Accepts Reasonable Expectation of Effectiveness Package for Loyal’s LOY-003
On September 16, the FDA accepted an interim submission for Loyal’s LOY-003 that includes a “reasonable expectation of effectiveness” (RXE) determination. This marks the third RXE granted to separate Loyal programs, according to the company. The RXE step evaluates whether a future drug can deliver the claimed benefit.
LOY-003 is a daily tablet designed for large and giant breeds that aims to extend their lifespan. Loyal links the shorter life of these dogs to the hormonal signals GH and IGF-1, which influence body growth. The tablet is intended
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PubMed Central (PMC)
Connecting serum IGF-1, body size, and age in the domestic dog
Many investigations in recent years have targeted understanding the genetic and biochemical basis of aging. Collectively, genetic factors and biological mechanisms appear to influence longevity in general and specifically; reduction of the ...
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