Nabriva gets FDA approval for novel antibiotic Xenleta

DUBLIN, IRELAND: Nabriva Therapeutics plc said that the US Food and Drug Administration (FDA) has approved its new drug Xenleta (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

Xenleta is available for oral (600 mg every 12 hours) and IV (150 mg every 12 hours) administration with a short 5-to-7-day course of therapy.

Nabriva expects Xenleta will be available through major U.S. specialty distributors in mid-September 2019. Xenleta will have a wholesale acquisition (WAC) price of $205 per IV patient treatment day and $275 per oral patient treatment day.

“Today’s approval of Xenleta is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,” said Ted Schroeder, chief executive officer of Nabriva Therapeutics.

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