What the sponsor asked the agency to accept
As the FDA restates it.
[sponsor's request as restated in the FDA review: not loaded]
What the agency said
T3 · ARIAConsistent
IQM-T3-1
Finally, we have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a known serious risk of amyloid related imaging abnormalities in patients who are homozygous for ApoE e4.
Approval letter · PDF p. 5 · action of · fda.gov ↗
Compared to LQT-T3-1, Leqembi, traditional approval, .
T3 · ARIAConsistent
IQM-T3-2
Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers.
Prescribing information (label) · PDF p. 3 · action of · fda.gov ↗
Compared to KIS-T3-1, Kisunla, traditional approval, .
Advisory committee
Your application for Leqembi IQLIK was not referred to an FDA advisory committee because this biologic is not the first in its class.
Approval letter · PDF p. 2 · action of · fda.gov ↗