NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.
The agency gave the designation to ACH-1625, a once-daily protease inhibitor that the company said could offer improved safety and tolerability, compared with existing drugs, convenience, fewer adverse interactions with drugs used to treat HIV and liver transplants and broader genotypic coverage of the virus. Current treatments typically involve a combination of oral pharmaceuticals and injected interferons, a type of biotech drug.
"We are very pleased with the granting of a fast track designation for ACH-1625, which we believe highlights this protease inhibitor's attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," Achillion president and CEO Michael Kishbauch said. "As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year."
Fast-track designation gives a drug maker greater access to the FDA and allows it to submit data for a regulatory approval application on a rolling basis while also opening the possibility for priority review by the agency.