Neurochem’s Alzheimer’s drug given fast track status

A fast-track designation speeds up the review process and is generally given to drugs that address an unmet need for serious or life-threatening conditions.

Neurochem said that it has scheduled a meeting with the FDA in August to discuss the Phase III program and present an update on the work accomplished to date on the North American Phase III trial. Neurochem will also seek the FDA’s feedback and validation on the next steps that would be acceptable to the agency, especially with respect to the statistical models, the company said.

In relation to the ongoing European Phase III clinical trial, patient screening activities will stop in August, as Neurochem has exceeded its original patient enrolment objectives. However, in light of the information and experience gained from the North American phase III clinical trial, Neurochem is presently considering modifications that would need to be made to the design of the European trial.