Nabi has received scientific advice from the European Medicines Agency (EMEA) on Nicvax, regarding the requirements for marketing authorization submission, as it relates to the appropriate design of the phase III clinical studies and safety data base.
This helps to ensure the performance of appropriate clinical studies so that no major objections regarding the design of studies will be raised during the evaluation phase.
Dr. Raafat Fahim, President and CEO of Nabi, said: We are very pleased to receive this scientific advice from the EMEA on this very important trial protocol including advice on specific primary and secondary endpoints. This advice clarifies what the EMEA feels is critical to evaluating the efficacy and safety of NicVAX from a licensing perspective”
The scientific advice reduces regulatory risk in the European Union associated with the NicVAX program and further strengthens our leadership position in bringing the first smoking cessation vaccine to market. We believe it also increases the attractiveness of our program to potential strategic partners. The advice we received confirms and supports our current phase III design which has recently been agreed to with the FDA through a Special Protocol Assessment (SPA). It is clear that smoking cessation represents a critical unmet medical need and a significant market opportunity for a safe and effective vaccine product, he added.