Pharma Focus Asia

FDA Grants Soligenix "Fast Track" Designation for RiVax® in the Prevention of Ricin Poisoning

Friday, February 14, 2020

Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).

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. Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics. For instance, 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. Additionally, BLAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

"We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received," stated Christopher J. Schaber, PhD, 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."

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