The “rolling” submission is an FDA provision, available to drug candidates that have received fast track designation, which allows for completed sections of a biologics license application (BLA) to be submitted on an ongoing basis.
The company has now submitted the chemistry, manufacturing and controls (CMC) section of that application and plans to file the preclinical section in April 2006. Provided that the data from its pivotal phase III trial for Veronate are satisfactory, the company expects to complete the BLA submission by filing the clinical section in the fall of 2006.
Inhibitex has also filed a request with the FDA for a priority review of the Veronate BLA. If granted, priority review generally provides for a six month review at the FDA once the complete BLA is submitted.
“The initiation of the rolling BLA for Veronate is an important regulatory milestone for the company, and the filing of our CMC section reflects our commitment to executing an accelerated regulatory strategy for Veronate,” stated Dr William Johnston, president and CEO of Inhibitex.
Additionall, the company has reported that the last infant enrolled in its pivotal phase III trial of Veronate completed the 70-day follow-up period on January 21, 2006. The company currently anticipates that the top-line results from this trial will be available in April 2006.