Idenix hepatitis C drug IDX719 gets FDA fast track designation...

Posted on 7-25-12 on businessweek.com. IDX719, Idenix's HCV NS5A inhibitor gets fast track designation from the FDA. 


July 25, 2012

CAMBRIDGE, Mass. (AP) — Shares of biotech drugmaker Idenix Pharmaceuticals Inc. rose Wednesday after the company said its experimental treatment for hepatitis C will be reviewed under the Food and Drug Administration's fast track program.



Drugs that receive fast track status at the FDA receive extra meetings and correspondence with regulators throughout the review process. The program is designed to speed up the approval of drugs that treat life-threatening diseases for which there are few other therapies.

Idenix has studied the safety and effectiveness of its drug, known as IDX719, in several small studies lasting up to seven days.

"We are pleased and encouraged by the receipt of fast track designation from the FDA for IDX719 as we believe this reflects the critical need for new treatment regimens to address HCV infection," said Idenix President and CEO Ron Renaud in a statement.

Shares of Idenix rose 24 cents, or 2.4 percent, to $10.31 in midday trading.