Eli Lilly To Seek Accelerated Approval Of Its New Alzheimer’s Drug
Following the "unprecedented" FDA approval of Biogen's controversial Alzheimer's drug, Eli Lilly is reportedly seeking speedy approval for its drug donanemab. Stat reports on how the drug's potential approval may play a part in the debate over Biogen's pricing.
Stat:
In Reversal, Eli Lilly Will Now Seek Fast Approval For Alzheimer's Treatment
Eli Lilly said Thursday that it will seek a fast U.S. approval for its drug to treat Alzheimer’s disease, taking advantage of the unprecedented regulatory path established by Biogen. The pharma giant intends to submit its drug called donanemab to the Food and Drug Administration by the end of the year. Lilly will request the agency grant the drug accelerated approval based on its ability to reduce amyloid plaques in the brain. (Feuerstein, 6/24)
Axios:
Eli Lilly To Apply For FDA Approval Of Unproven Alzheimer's Treatment
Eli Lilly plans on filing an application for an "accelerated approval" of its experimental Alzheimer's treatment, donanemab, with the FDA later this year, the pharmaceutical company said today. The FDA possibly set a new precedent for more unproven Alzheimer's drugs to gain the agency's stamp of approval, after it gave a controversial conditional approval to Biogen's Alzheimer's drug earlier this month. (Herman, 6/24)
Stat:
Will FDA Quickly Review A Lilly Drug To Alleviate Cost Concerns For Alzheimer's Treatments?
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). (Silverman, 6/24)
Also —
ABC News:
Doctors Face Dilemma On Whether To Recommend New Alzheimer's Treatment
This month, the Food and Drug Administration approved a new treatment for Alzheimer’s disease -- the first in nearly 20 years. But the decision was not without controversy, with doctors split on how they feel about the treatment. Since the approval, doctors have faced questions from patients and families desperate for good news, but they are conflicted on whether to recommend and prescribe the new drug, developed by Biogen. (Leyden, 6/24)
