Paratek Pharmaceuticals said Wednesday that an FDA advisory committee recommended approval of intravenous and oral formulations of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) as well as community-acquired bacterial pneumonia (CABP). The panel voted 17-1 in favour of approval of the therapy for treating ABSSSI, while voting 14-4 in support of authorising the treatment for CABP. Paratek CEO Michael Bigham stated "we look forward to working with the FDA as it considers the comments from the committee members and completes its review of the omadacycline new drug applications."
The panel recommendations were supported by safety and efficacy data from three late-stage studies of the oral and intravenous versions of omadacycline. Study data unveiled in June showed efficacy of the therapy compared to placebo in the treatment of patients with ABSSSI, while data announced in May supported the drug's efficacy against CABP.
Guggenheim analysts have projected sales of $343 million for omadacycline in the treatment of CABP, with forecast of $192 million for use in patients with ABSSSI by 2025.
Paratek's filing seeking approval of omadacycline for use in these indications was accepted for priority review by the FDA in April.
For related analysis, see ViewPoints: Paratek in prep mode as commercialisation looms for omadacycline.
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