Neurochem’s Alzhemed Gets Fast Track

Neurochem said Tuesday the U.S. Food and Drug Administration granted fast track status to Alzhemed, a potential Alzheimer’s disease treatment.

Neurochem said it has scheduled an August meeting with the FDA’s division of neurology products to discuss Alzhemed’s phase 3 program. The company plans to present the FDA an update on the North American phase 3 trial of the drug and seek the agency’s recommendations on the next steps, particularly relating to the statistical models.

Neurochem announced in April that it was making an adjustment to the initial statistical model of the North American phase 3 results. The company locked the database and was conducting a detailed analysis of potential confounding factors, including the baseline characteristics of the study population.

Neurochem said patient screening activities in the ongoing European phase 3 trial will stop in August because the company has exceeded its enrollment objectives. But Neurochem is considering modifications to the design of the trial in light of information gained from the North American phase 3 trial.