In an unexpected move, U.S regulators granted Eli Lilly (LLY) a breakthrough designation for its experimental Alzheimer’s drug, raising intriguing questions about competition and pricing in a quickly evolving marketplace already filled with controversy.
This was the second time this week, in fact, that the Food and Drug Administration granted this type of designation to an Alzheimer’s drug being developed, the other bestowed on Biogen (BIIB) and Eisai (ESALY). The companies earlier this month won approval for their Aduhelm medication despite furious debate over clinical data, regulatory standards, and the ensuing cost to the U.S. health care system.
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