Accelerated approval and priority review are specific regulatory programs developed by the FDA to expedite the availability of products addressing important needs. ID Biomedical and the FDA’s Center for Biologics Evaluation and Research (CBER) have outlined a clinical trial program that will allow ID Biomedical to submit a biologics license application (BLA) later this year.
Approval to market Fluviral in the US will be based on achieving agreed-upon safety and immunogenicity endpoints from clinical trials that are already ongoing in Canada and the US.
ID Biomedical believes it will be able to gather this data and, if positive, file a BLA by the end of 2005. If the data and inspection of ID Biomedical’s manufacturing facilities are acceptable, the company will be in the position to manufacture and ship the influenza vaccine to the US market in 2006.
“We are extremely pleased with the collaborative relationship we have established with CBER, and their clear recognition of the importance of expanding US influenza vaccine availability,” said Dr Anthony Holler, ID Biomedical’s CEO. “Obviously nothing is guaranteed and we have a lot of work to do, but we are optimistic we can be in the US market by next year, or a year ahead of expectations.”
The company also announced that the ongoing expansion and upgrading of its Quebec-based flu vaccine manufacturing facilities is on schedule. This expansion will increase total manufacturing capacity to approximately 50 million doses by 2007, and will house what is believed to be the newest egg-based vaccine production facility in the world.