Nabriva’s Xenleta (lefamulin) Receives FDA’s Approval for the Treatment of Community-Acquired Bacterial Pneumonia in Adults

Shots:

• The US FDA’s approval is based on two P-III studies, LEAP 1 & LEAP 2. LEAP 1 involves assessing of Xenleta (150mg IV/600mg oral for 5-7days) vs moxifloxacin (IV/oral for 7days) with/out linezolid in patients with CABP which demonstrated non-inferiority to moxifloxacin i.e, ECR rate (87.3% vs 90.2%)
• The P-III LEAP 2 study involves assessing of Xenalta (PO for 5days) vs moxifloxacin (PO for 7days) in resulted in achieving similar ECR rates in IIT population
• Xenleta (lefamulin) is a semi-synthetic pleuromutilin antibiotic positioned for use as a 1L therapy for CABP, targeting in vitro spectrum of activity against Gram+ and Gram- pathogens associated CABP and has received FDA’s QIDP & FT designation with its expected availability in mid-Sept’2019

Click here to­ read full press release/ article | Ref: Nabriva | Image: Pitchbook