If the agency agrees with its advisers, the drug would only be the second Alzheimer's drug approved to slow cognitive decline due to Alzheimer's.
If the agency agrees with its advisers, it would only be the 2nd drug approved to slow cognitive decline due to Alzheimer'sFederal health advisers have endorsed a closely watched Alzheimer's drug from Eli Lilly for people with mild dementia.
"I thought the evidence was very strong in the trial showing the effectiveness of the drug," said panel member Dean Follmann, a National Institutes of Health statistician. "Imposing a requirement for tau imaging is not necessary and would raise serious practical and access concerns to the treatment," said Dr. Thomas Montine of Stanford University, who chaired the panel and summarized its opinion.
In another key difference, Lilly studied taking patients off its drug when they reached very low levels of amyloid, a sticky brain plaque that's a contributor to Alzheimer's.
Alzheimer Drug Eli Lilly Eli Lilly Alzheimer Durg Donanemab Alzheimer Drug Eli Lilly New Alzheimer Drug Lilly Alzheimer Dementia 14935236
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
High Confidence Alzheimer's Drug Donanemab Will Get FDA Panel NodAn FDA advisory committee will meet June 10 to offer its opinion on whether the agency should greenlight donanemab for Alzheimer's disease.
Read more »
FDA analysis raises no major concerns about Eli Lilly Alzheimer's drugAn FDA analysis of trial data for Eli Lilly's experimental Alzheimer's drug donanemab released on Thursday revealed no red flags, but raised questions about safety of the treatment for patients with early-stage disease.
Read more »
Alzheimer's drug that can slow disease gets backing from FDA advisersFederal health advisers have endorsed a closely watched Alzheimer’s drug from Eli Lilly for people with mild dementia. The FDA will make the final decision on approval later this year. If the agency agrees with its advisers, the drug would only be the second Alzheimer’s drug clearly shown to slow cognitive decline due to Alzheimer’s.
Read more »
FDA advisors recommend Eli Lilly's Alzheimer's drug donanemab, paving way for approvalIf approved, Eli Lilly's donanemab would become the second Alzheimer's drug of its kind to enter the market after Leqembi from Biogen and Eisai.
Read more »
FDA advisors recommend Eli Lilly's Alzheimer's drug donanemab, paving way for approvalIf approved, Eli Lilly’s donanemab would become the second Alzheimer’s drug of its kind to enter the market after Leqembi from Biogen and Eisai.
Read more »
Alzheimer's drug that can slow disease gets backing from FDA advisersFederal health advisers have endorsed a closely watched Alzheimer’s drug from Eli Lilly for people with mild dementia.
Read more »