Loading...
Market
Who will lead the Alzheimer's treatment market by end of 2025?
2
Resolution / Starting Odds
LEQEMBI leads market • 25%
Competitor drug leads market • 25%
No clear market leader • 25%
Other • 25%
Market analysis reports from healthcare industry analysts
Story
FDA Accepts Biogen and Eisai's LEQEMBI BLA for Subcutaneous Alzheimer's Treatment, PDUFA Date Set
Jan 15, 2025, 01:48 PM
The U.S. Food and Drug Administration (FDA) has accepted Biogen Inc. and Eisai Co. Ltd.'s Biologics License Application (BLA) for LEQEMBI (lecanemab-irmb), a treatment for early Alzheimer's disease, with a PDUFA action date set for August 31, 2025. The application seeks approval for a subcutaneous autoinjector (SC-AI) for weekly maintenance dosing, allowing for at-home administration. This development follows the announcement by Biogen and Eisai of the completion of the filing submission with the FDA.
View original story
Similar markets
No dominant company • 25%
Eli Lilly • 25%
Eisai and Biogen • 25%
Other companies • 25%
Other treatments lead • 25%
Both have equal share • 25%
Leqembi leads • 25%
Donanemab leads • 25%
2-3 new treatments • 25%
4-5 new treatments • 25%
0-1 new treatments • 25%
More than 5 new treatments • 25%
China • 25%
United States • 25%
European Union • 25%
Other • 25%
Yes • 50%
No • 50%
No • 50%
Yes • 50%
No • 50%
Yes • 50%
Rejected by FDA • 25%
Withdrawn by manufacturer • 25%
FDA approved and in market • 25%
Pending approval • 25%
Another competitor • 34%
Eli Lilly • 33%
Novo Nordisk • 33%
Viking Therapeutics • 25%
Other • 25%
Eli Lilly • 25%
Novo Nordisk • 25%
More than 20% • 25%
10% to 20% • 25%
5% to 10% • 25%
Less than 5% • 25%