What the sponsor asked the agency to accept
As the FDA restates it.
In this BLA supplement, the Applicant is seeking traditional approval of lecanemab.
Approval package (reviews) · PDF p. 63 · action of · fda.gov ↗
What the agency said
T1 · SurrogateConsistent
LQT-T1-1
These approvals were based on a demonstration of reduction of amyloid beta on PET imaging, a surrogate endpoint that was determined to be reasonably likely to predict clinical benefit.
Approval package (reviews) · PDF p. 50 · action of · fda.gov ↗
Compared to LEQ-T1-1, Leqembi, accelerated approval, .
T2 · Effect sizeConsistent
LQT-T2-1
The effect on the primary endpoint represents a clinically meaningful reduction of clinical decline.
Approval package (reviews) · PDF p. 51 · action of · fda.gov ↗
Compared to LEQ-T2-1, Leqembi, accelerated approval, .
T3 · ARIAConsistent
LQT-T3-1
Since Leqembi was approved on January 6, 2023, we have become aware of clinical trial data showing an increased risk of symptomatic, serious, and severe radiographic amyloid related imaging abnormalities (ARIA) in ApoE ε4 homozygotes who are treated with Leqembi compared to heterozygotes and noncarriers.
Supplement approval letter · PDF p. 10 · action of · fda.gov ↗
Compared to LEQ-T3-1, Leqembi, accelerated approval, .
T3 · ARIADeparts
LQT-T3-2
Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
Prescribing information (label) · PDF p. 2 · action of · fda.gov ↗
Compared to LEQ-T3-3, Leqembi, accelerated approval, .
T4 · DataConsistent
LQT-T4-1
The collective evidence from Study 201 and 301 continue to demonstrate substantial evidence of effectiveness for lecanemab for the treatment of Alzheimer’s disease, and support the traditional approval of lecanemab in this population.
Approval package (reviews) · PDF p. 51 · action of · fda.gov ↗
Compared to LEQ-T4-1, Leqembi, accelerated approval, .
T5 · ConfirmatoryConsistent
LQT-T5-1
We have reviewed your submission and conclude that the above requirement was fulfilled.
Supplement approval letter · PDF p. 10 · action of · fda.gov ↗
Compared to LEQ-T5-1, Leqembi, accelerated approval, .
Committee votes
Peripheral and Central Nervous System Drugs Advisory Committee, . Read from Advisory committee minutes (June 9, 2023), which reproduces the questions and results.
| Question | Yes | No | Abstain | Source |
|---|---|---|---|---|
| Q2 Do the results of Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? | 6 | 0 | 0 | p. 5 ↗ |