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iADRS (Integrated Alzheimer's Disease Rating Scale)

Neurologyยท appears in 97+ cited findings in this library

What it is and how the reviews use it

The Integrated Alzheimer's Disease Rating Scale (iADRS) is an endpoint used in regulatory reviews for Alzheimer's disease treatments. The iADRS score ranges from 0 to 144, as defined in the Eli Lilly and Company โ€” Kisunla FDA Review (BLA761248, ORIG 1, 2024) on page 32. This scale is designed to measure the overall impact of Alzheimer's disease.

Regulatory reviews in this library utilize iADRS to assess treatment efficacy. For instance, the Eli Lilly and Company โ€” Kisunla EMA EPAR public assessment report (EME, p.147) noted an iADRS โ‰ฅ13.5 point decrease HR (overall population) of 0.702. The Eli Lilly and Company โ€” Kisunla FDA Review (BLA761248, ORIG 1, 2024) on page 48 reported an iADRS change from baseline of -22.3%. Additionally, the EISAI INC โ€” Leqembi FDA Review (NDA/BLA 761269, 2024) on page 163 showed a modified iADRS percent difference vs. placebo (FAS+ population) of -30%.

Real examples โ€” cited to the source page

KisunlaiADRS โ‰ฅ13.5 point decrease HR (overall population)0.702Eli Lilly and Company โ€” Kisunla EMA EPAR public assessment report, p.147
KisunlaiADRS change from baseline-22.3%Eli Lilly and Company โ€” Kisunla FDA Review, p.48
Leqembimodified iADRS percent difference vs. placebo (FAS+ population)-30%EISAI INC โ€” Leqembi FDA Review, p.163

Different drugs were studied in different trials โ€” these values are not head-to-head comparisons.

Explore the full evidence

Every iADRS finding in the library โ€” searchable and answerable in plain language โ€” is in the Neurology research library โ†’

Figures are as stated in the cited source documents. Educational reference only โ€” not medical or investment advice.

iADRS (Integrated Alzheimer's Disease Rating Scale) โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Neurology