DECODE AND FDA AGREE ON TRIAL DESIGN
DeCode genetics has reached an agreement with the FDA on the design of its Phase III clinical trial for DG031, the company's lead developmental compound for the prevention of heart attack.
The special protocol assessment (SPA) enables DeCode to proceed with the recruitment of participants for the Phase III trial. The SPA is an agreement between the FDA and DeCode on the objectives, design, primary endpoints and statistical analysis plan for the trial.
Achievement of the pre-specified endpoints would fulfill requirements to support regulatory approval for a new drug application for DG031.