Never. Should. Get. Approved.
Biogen, Eisai unveil new data on lecanemab, but questions linger on ARIA-E; Spatial biology outfit grabs $33M round – Endpoints News
Biogen, Eisai unveil new data on lecanemab, but questions linger on ARIA-E; Spatial biology outfit grabs $33M round
Eisai and Biogen have released more data on lecanemab, another anti-Alzheimer’s drug in the partnership that spawned aducanumab. However, questions about the data remain when looking at ARIA-E events, with the typical caveat of cross-trial comparisons.
The data from lecanemab’s Phase IIb study were presented at the annual AD/PD meeting, and the ratio of ARIA-E — a type of amyloid-related imaging abnormalities resulting in brain bleeds — appeared higher than in Aduhelm studies when compared to placebo. Two trials on the highly controversial drug, ENGAGE and EMERGE, showed a 41% decrease in amyloid plaque, compared to 10% in the placebo arm. That was a 4:1 ratio.
But for lecanemab, the overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with the drug’s 10 mg/kg dose biweekly, compared with 0.8% (2/245) of placebo patients, according to the companies. That results in a much higher ratio of ARIA-E events, with more than 12 times as many.
Lecanemab is in the middle of a Phase III trial, which is expected to have a readout sometime this fall.
Biogen, Eisai unveil new data on lecanemab, but questions linger on ARIA-E; Spatial biology outfit grabs $33M round – Endpoints News
Biogen, Eisai unveil new data on lecanemab, but questions linger on ARIA-E; Spatial biology outfit grabs $33M round
Eisai and Biogen have released more data on lecanemab, another anti-Alzheimer’s drug in the partnership that spawned aducanumab. However, questions about the data remain when looking at ARIA-E events, with the typical caveat of cross-trial comparisons.
The data from lecanemab’s Phase IIb study were presented at the annual AD/PD meeting, and the ratio of ARIA-E — a type of amyloid-related imaging abnormalities resulting in brain bleeds — appeared higher than in Aduhelm studies when compared to placebo. Two trials on the highly controversial drug, ENGAGE and EMERGE, showed a 41% decrease in amyloid plaque, compared to 10% in the placebo arm. That was a 4:1 ratio.
But for lecanemab, the overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with the drug’s 10 mg/kg dose biweekly, compared with 0.8% (2/245) of placebo patients, according to the companies. That results in a much higher ratio of ARIA-E events, with more than 12 times as many.
Lecanemab is in the middle of a Phase III trial, which is expected to have a readout sometime this fall.