Eli Lilly's Alzheimer's Drug, Donanemab Faces FDA's Adcomm Vote Next Week On Data, Risk Profile

On Monday, June 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet to discuss and vote on whether the data from Eli Lilly And Co’s LLY Phase 3 Study AACI (TRAILBLAZER-ALZ 2) support a favorable benefit-risk assessment for the use of donanemab for Alzheimer’s disease.

In March last year, Eli Lilly released the results of the TRAILBLAZER-ALZ 2 Phase 3 study of donanemab for Alzheimer’s disease.

The document notes that the phase 2 study’s statistically significant result for the integrated Alzheimer’s Disease Rating Scale (DRS) further supports the efficacy of donanemab.

The iADRS combines scores from two widely accepted measures, the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study – instrumental Activities of Daily Living (ADCS-iADL).

The findings on iADRS were supported by the statistically significant results of CDR-SB an integrated scale to assess daily function and cognitive effects, and any increment of change on an individual domain of the CDR-SB is considered to be clinically meaningful for an individual patient.

Donanemab treatment demonstrated a statistically significant reduction in decline on CDR-SB change from baseline at Week 76 compared to placebo in the overall population.

Further, the meaningfulness of the change is supported by statistically significant changes in cognition on the ADAS-cog and daily function on the ADCS-iADL scale.

Brain Aβ measured by PET was significantly reduced in a time-dependent manner.

Read Next: Eli Lilly’s Donanemab For Alzheimer’s Hits FDA Speed Breaker, Biogen Stock Gains On Delayed Decision.

Price Action: LLY shares are up 0.75% at $838.01 at the last check on Thursday.

Photo by Gerd Altmann via Pixabay