NUNZIUM

Eli Lilly's experimental drug donanemab has demonstrated positive results in slowing cognitive and functional decline in early-stage Alzheimer's patients, marking a significant breakthrough in the treatment of the disease. The TRAILBLAZER-ALZ 2 Phase 3 study revealed that donanemab slowed decline by 35% over 18 months using the integrated Alzheimer's Disease Rating Scale (iADRS) measure. The company aims to file for FDA approval by the end of June, with potential approval by H1 2023.

Alzheimer's disease affects over 6 million Americans, with an estimated 1.7 million to 2 million people over 65 in early stages. Drug development for Alzheimer's has seen numerous failures, but Lilly's drug is among a new group, including Eisai and Biogen's Leqembi, which received accelerated FDA approval in January, showing promise in treatment.

Donanemab works by removing amyloid plaque buildups in the brain, believed to be responsible for Alzheimer's progression. Administered by infusion once a month, 52% of trial patients were able to stop taking the medicine by one year, and 72% by a year and a half. Researchers observed a 35% slowing in cognitive and functional decline in the group with intermediate levels of tau, a brain protein. When combined with the group with higher levels of tau, the figure was 22%.

The late-stage trial, involving 1,182 participants, showed that 50% of patients who received donanemab experienced no worsening of Alzheimer's symptoms after a year, while 71% of patients on placebo saw disease progression. However, side effects include brain swelling or abnormalities, with at least two deaths linked. More data is needed to determine if donanemab is truly different from Leqembi in terms of benefits and risks.

Leqembi is not currently covered by Medicare, but full FDA approval could change this as early as July. The potential pricing for donanemab has not been discussed before approval. If approved, donanemab could generate $7.5 billion a year for Lilly at its peak.

Eli Lilly's Q1 revenue dropped 11% due to declining sales of its coronavirus antibody treatment. However, the success of donanemab could mark a turning point for the company and bring hope to millions of Alzheimer's patients worldwide. The full results of the TRAILBLAZER-ALZ 2 study will be presented at the Alzheimer's Association International Conference in July, providing further insight into this promising new treatment option.