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Replies to post #302910 on Anavex Life Sciences Corp (AVXL)
Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer's disease.
03/13/21 8:32 PM
The safety profile of donanemab was consistent with observations from Phase 1 data. In the donanemab treatment group, amyloid-related imaging abnormalities – edema (ARIA-E) occurred in 26.7 percent of treated participants, with an overall incidence of 6.1 percent experiencing symptomatic ARIA-E; the majority ARIA-E cases occurred within the first 12 weeks after initiation of treatment. Other common AEs in the donanemab treatment group include ARIA-H related events like microhemorrhages (7.6 percent) and superficial siderosis of central nervous system (13.7 percent), nausea (10.7 percent), and infusion-related reaction (IRR) (7.6 percent). Serious IRR or hypersensitivity occurred in 2.3 percent of participants treated with donanemab. In the donanemab arm, 30.5 percent of patients discontinued treatment due to an adverse event and half of these discontinuations were due to ARIA-related events. Patients with treatment discontinuations were allowed to continue in the trial.
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