BIIB - Eli Lilly full phase 3 data confirms benefit of Alzheimer's asset donanemab

2023-07-17 13:21:00 ET

Complete phase 3 data released on Eli Lilly's ( NYSE: LLY ) donanemab confirmed that the Alzheimer's biologic was effective in slowing cognitive decline in early stages of the disease compared to placebo.

Yet, as is the case with Biogen ( BIIB ) and Eisai's ( OTCPK:ESAIY )( OTCPK:ESALF ) already approved Leqembi (lecamemab), the efficacy results were tempered by instances of brain swelling or bleeding. Three patients receiving donanemab died from this and 24% of those receiving the biologic had evidence of it.

In the study of ~1700 participants with early symptomatic Alzheimer's, patients in the donanemab arm saw their cognitive decline slow by 22% on one scale and 29% on another compared to the placebo group. The measures are, respectively, the integrated Alzheimer's Disease Rating Scale (iADRS) and the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

Results indicated that donanemab may work better in those with earlier stages of memory impairment. Those with low to medium levels of tau in their brain saw their decline slow by 35% and 36%, respectively, on those same scales.

Tau, like amyloid, is a protein typically found in the brains of Alzheimer's patients and is thought to play a role in the disease. More tau usually indicates more advanced disease.

Lilly ( LLY ) noted that many participants saw their treatment effect continue to improve even though they stopped receiving the therapy at six or 12 months. Patients were followed for 18 months.

The results unveiled Monday at both the Alzheimer's Association International Conference and in the Journal of the American Medical Association reinforce partial data released in May from the TRAILBLAZER-ALZ 2 trial .

Lilly is expecting the US FDA to make a decision on donanemab by the end of the year after the agency in January rejected its attempt for accelerated approval .

More on donanemab

Eli Lilly's Donanemab: The Anti-Amyloid Saga Continues

Eli Lilly's Alzheimer's Breakthrough: A Game Changer For Investors And Patients

Lilly's New Donanemab Data For Alzheimer's

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