Another NS5A drug that looks very promising receives "Fast Track" status

[willbb]

IDX719 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection

CAMBRIDGE, Mass., July 25, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IDX719 for the treatment of chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.

"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," stated Ron Renaud, President and Chief Executive Officer of Idenix. "We remain focused on executing our goal of creating an interferon-free direct acting antiviral combination to cure HCV for a patient population that currently has limited treatment options. As previously reported, we are on track to initiate a phase II combination study of IDX719 with IDX184, our other lead HCV product candidate, by the end of this year."

Under the FDA Modernization Act of 1997, Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, rather than waiting for the entire submission prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which would reduce the length of the standard FDA review period.

[can-do-man]

Just getting ready to initiate a phase II study by the end of this year... Looks like were still a few years away for this.

[willbb]

I wish fast-tracked " meant that in the true sense. They can sometimes "crawl around " even after this designation jules,,however at least a step in the right direction

Hope you are doing well..
Will

[jules2551]

" This permits the FDA to review the filing as it is received, rather than waiting for the entire submission prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which would reduce the length of the standard FDA review period."

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This is fantastic news!  Fast Track?  They usually crawl around the track.  Thanks Will