Eli Lilly and Co plans to seek US approval for its experimental Alzheimer’s drug by the end of the year, as reported in Reuters.
This comes in the wake of Biogen’s approval for its drug, Aduhelm, which led to much controversy, but may have also paved the way for other companies to focus on treatments for the untreatable disease.
Several companies, including Lilly, have been hoping to bring similar drugs to market, Eli Lilly shares were up by 4%.
Eli Lilly plans to submit data to regulators demonstrating that the drug more effectively cleared amyloid beta brain plaques than any other treatment.
Chief Scientific Officer Daniel Skovronsky told investors on a call to discuss quarterly results: “If you believe that lowering amyloid plaque is a good thing to do, you’re going to want the drug that lowers amyloid plaque the most.
“There will be some physicians, I’m sure as are today, who still say I don’t want to use a drug until I have cognitive data.”
The FDA has come under much criticism for its approval of Aduhelm, with some naming it the worst drug approval in recent history, whilst three FDA panel members quit in protest.
The FDA is currently undertaking its own internal investigation into the approval process of the drug, a highly unusual move, to better understand how a drug with so little data managed to get the green light.
Eli Lilly said it was conducting a Phase III trial to prove the drug also helps slow cognitive decline in patients, and expects that study to be completed by 2023.]
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