Fast track designation is given to drugs that promise to fulfill unmet medical needs for serious diseases. The designation should allow for an accelerated review process, potentially bringing Civacir closer to being released on the market.
“The fast track designation provided by the FDA not only acknowledges Civacir as a viable potential treatment option for HCV patients, but it also recognizes that current therapies are inadequate,” commented Dr Henrik Rasmussen, senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals.
After recent discussions with regulators in the US and EU, Nabi said that it believes that a proof-of-concept phase II trial, followed by a single pivotal phase III study, would be adequate for licensure of the drug.
The phase II proof-of-concept study will be designed to add to the knowledge of how Civacir works and the levels of antibodies needed to protect the transplanted liver from re-infection with the virus.