FDA 'Fast Tracks' Achillion's once-daily pan-genotypic protease inhibitor ACH-1625...

From Hartford Business.com Federal drug regulators have "fast tracked'' one of the drugs that New Haven's Achillion Pharmaceuticals Inc. has developed to treat chronic sufferers of hepatitis C, hastening its potential commercial availability. The U.S. Food and Drug Administration (FDA) cleared ACH-1625, a once-a-day dosage, for the chronic liver disease currently being evaluated in a Phase 2 clinical trial. The 15-year-old fast track designation means the drug has shown better safety and tolerability, more convenient dosing and the potential to treat a wider universe of patients than existing treatments, Achillion CEO Michael Kishbauch said Wednesday. It allows regulators to review Achillion's ACH-1625 data as it becomes available, rather than waiting for it all to be collected and bundled into a single, bulky application. Doing it this way, authorities say, also allows for more frequent interaction between Achillion and FDA investigators, which could shorten the development and review period