Donanemab: Delay in Alzheimer's Drug Approval

Delay in Alzheimer's Drug Approval Raises Confusion and Hope

The approval of the Alzheimer's drug Donanemab in the US is being delayed. Originally expected for spring 2023, the date now seems to have been postponed.

 

Confusion and doubts

Many wonder if the side effects associated with Donanemab, called ARIA-E and ARIA-H, are so serious that the approval is in question.

 

Detailed study results

• Donanemab is the most effective beta-amyloid antibody to date that has slowed the progression of mild dementia in a clinical trial.
• In the TRAILBLAZER ALZ 2 study, Donanemab was able to limit the decline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo (1.20 points vs. 1.88 points).
• However, side effects occurred: ARIA-E (24.0% vs. 2.1% in the placebo group) and ARIA-H (31.4% vs. 13.4% in the placebo group). In the Donanemab group, 3 deaths were linked to ARIA changes.

 

FDA re-examines

The FDA is taking these results seriously and is re-examining the study to ensure maximum efficacy and safety for patients.

 

Hope despite delay

ARIAs can be reduced and stopped with close monitoring. In the study, treatment could even be paused in half of the participants because the amyloid load was significantly reduced.

 

Conclusion

Donanemab is a promising drug for Alzheimer's patients. The delay in approval is unfortunate, but the strong efficacy gives hope that Donanemab will come to market – sooner or later.

 

 

Reference:
The TRAILBLAZER-ALZ 2 Randomized Clinical Trial