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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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