Princeton-based Soligenix Inc. a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, said Thursday that its RiVax (heat-stable ricin toxin vaccine) development program for prevention of ricin intoxication has received “fast track” designation from the U.S. Food and Drug Administration (FDA).
“We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received,” said Christopher Schaber, president and chief executive officer of Soligenix. “We believe that the FDA’s action in granting fast track designation validates the unmet medical need that currently exists for a vaccine providing protection against lethal ricin toxin exposure and for the potential key role RiVax can serve as a part of the US Strategic National Stockpile,” said Schaber.
Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The practice is intended to facilitate the development, and expedite the review, of new drugs and biologics. For example, should events warrant, Soligenix will be eligible to submit a biologics license application (BLA) for RiVax on a rolling basis, permitting the FDA to review sections of the BLA prior to receiving the complete submission.
In addition, BLAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.