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FDA Committee Backs Omadacycline for CABP, ABSSSI Indications
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In a trio of phase 3 studies, omadacycline met the FDA-designated primary and secondary efficacy outcomes while reporting consistent safety measures and tolerability.
A US Food and Drug Administration (FDA) advisory committee has voted favorably for the eventual approval of both intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
The Antimicrobials Drug Advisory Committee of the FDA voted 17-1 and 14-4, respectively, for the indications for omadacycline, the modernized tetracycline from Paratek Pharmaceuticals.
With the approved recommendations, the advisory committee had reviewed data from the omadacycline global development program—a portfolio featuring a trio of phase 3 trials evaluating the safety and efficacy of the once-daily IV and oral formulations in patients with ABSSSI or CABP.
Across the trials, nearly 2000 adult patients were administered the therapy. In all 3 studies, omadacycline met the FDA-designated primary and secondary efficacy outcomes while reporting consistent safety measures and tolerability, leading to the majority votes that substantiated its safety and efficacy for both ABSSSI and CABP.
Omadacycline is also being considered for urinary tract infection indications. The tetracycline is designed specifically to overcome tetracycline resistance and express activity across various bacteria in patients.
In addressing the positive committee support, Paratek chairman and chief executive officer Michael F. Bigham said omadacycline has the potential to help in addressing an “urgent and growing need for new antibiotics to treat serious community-acquired infections.”
“With once-daily dosing and bioequivalent IV and oral formulations, omadacycline may help facilitate early discharge from the hospital or, in other cases, allow for safe and effective treatment in the outpatient setting," Bigham said in a statement. "Today's recommendations from the Advisory Committee move us one step closer to making this important new treatment option available to patients and physicians.”
A Prescription Drug User Fee Act (PDUFA) date for both new drug applications is scheduled for early October.
