Anavex Pushes for Alzheimer’s Drug Re-Evaluation After Revised Trial Data

Amid a global surge in Alzheimer’s diagnoses, a biotech company is gambling its future on a re-evaluation of a drug regulators once deemed ineffective.

Anavex is seeking regulatory re-evaluation of its Alzheimer’s drug, ANAVEX2-73 (blarcamesine), following new clinical trial data. The FDA previously rejected the drug in 2023 due to insufficient evidence of cognitive benefits.

Anavex claims updated analysis of the Phase 3 trial shows a statistically significant improvement in cognitive scores for patients with mild-to-moderate Alzheimer’s.

Anavex CEO said:

"We believe the revised data package provides a compelling case for re-evaluation and potential approval."

The FDA has not yet confirmed whether it will accept the new submission. Original trial results showed marginal improvements in cognitive tests but failed to meet primary endpoints in 2022.

The drug’s mechanism as a sigma-1 receptor agonist remains under scrutiny, with regulators requiring robust evidence of clinical benefit under their stated approval criteria.

⚠️ LEGAL DISCLAIMER: It is for informational purposes only. It never substitutes for professional medical advice, diagnosis, or treatment. Always consult your doctor regarding any questions about your health.