Following a positive recommendation from its Antimicrobial Drug Discovery Committee in August, the US Food and Drug Administration has now approved Nuzyra (omadacycline).
Developed by US firm Paratek Pharmaceuticals (Nasdaq: PRTK), Nuzyra is cleared for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). The company plans on making Nuzyra available in the first quarter of 2019.
Omadacycline could bring in US sales of $192 million as a treatment for skin infections and $343 million as a therapy for pneumonia by 2025, according to brokerage Guggenheim Securities at the time of the FDA advisory.
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