Posted by Michael Wonder on 31 May 2020
Nabriva Therapeutics receives positive EU CHMP opinion for Xenleta (lefamulin) for the treatment of community-acquired pneumonia
29 May 2020 - If approved, Xenleta has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous and oral treatment of adult patients with community-acquired pneumonia in Europe.
Nabriva Therapeutics announced today that the CHMP of the EMA has adopted a positive opinion recommending approval of Xenleta (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed.
The CHMP recommendation for marketing authorisation is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants.
