Fast track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists. Fast track regulations are also designed to expedite the review process for designated products, including the potential for companies to ask for priority review.
NicVax is designed to cause the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain. It is believed that these nicotine antibodies will act like a “sponge” soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain.
“We believe this is the first fast track designation for a smoking cessation product candidate, which is unprecedented, and provides further validation for our unique approach to addressing nicotine addiction,” stated Dr Henrik Rasmussen, senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals.