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news.ActivBiotics has been granted fast track designation by the FDA for its lead product candidate, rifalazil, for the symptomatic treatment of peripheral arterial disease, otherwise known as PAD.
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Fast track designation is reserved for new drugs that demonstrate the potential to address a significant unmet medical need and are intended for the treatment of a serious or life-threatening condition.
In granting fast track designation to the drug, the agency noted that current approved treatments for PAD do not target underlying contributors to disease progression, thought to be related to infection with Chlamydia pneumonia.
Rifalazil, a bactericidal anti-chlamydial agent, has the potential to eliminate this possible underlying cause of PAD.
“We are extremely pleased to receive endorsement of our lead clinical program in the form of this fast track approval,” said Dr Steve Gilman, president and CEO. “We expect fast track designation to potentially facilitate development and expedite review of our regulatory submissions as we move towards approval.”