Hepatitis C Drug PSI-938 Granted FDA Fast-track Designation

Fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition.

Clinical-stage pharmaceutical company Pharmasset has received fast-track designation from the FDA for PSI-938, a hepatitis C drug.

Under the FDA Modernization Act of 1997, fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

PSI-938 was granted the fast-track designation due to the need for hepatitis C treatments with improved tolerability, safety and efficacy over the existing standard of care.

The latest study of the oral drug shows that the treatment has potent antiviral activity and is generally safe