No Safety Shortcuts Under Breakthrough Designation, Synthetic Biologics Finds

Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.

Breaking through wall — Please wear your safety googles when attempting a breakthrough.

The narrative surrounding the US FDA’s Breakthrough Therapy Designation (BTD) program has largely focused on its successes in expediting drugs with promising preliminary efficacy for serious unmet medical needs, but the loss of Synthetic Biologics Inc.’s designation for ribaxamase highlights the agency’s strict scrutiny of safety data as well.

Synthetic Biologics voluntarily withdrew the BTD after FDA further reviewed data and analyses from the Phase IIb trial that supported...

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