FDA Agrees Loyal Data Supports Reasonable Expectation of Effectiveness for Large Dog Lifespan Extension
“Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Loyal CEO Celine Halioua.
- “Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Loyal CEO Celine Halioua.
- It’s 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.
- It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness and, once the FDA approves Loyal’s manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population.
- The Center for Veterinary Medicine at the FDA has reviewed Loyal’s data, results, and scientific arguments and determined they provide reasonable expectation of the drug’s effectiveness to extend canine lifespan and healthspan.