CHMP recommends approval of Xenleta for community-acquired pneumonia.- Nabriva Therapeutics

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xenleta (lefamulin), from Nabriva Therapeutics, intended for the treatment of community-acquired pneumonia (CAP) in adults. Xenleta will be available as a 150 mg concentrate and solvent for solution for infusion and 600 mg film-coated tablets.

The active substance of Xenleta is lefamulin, a pleuromutilin antibacterial for systemic use (ATC code: J01XX12) which inhibits bacterial protein synthesis. The benefit with Xenleta is its ability to treat community-acquired pneumonia, as shown in two large clinical trials.

The most common side effects are diarrhoea, nausea, vomiting, hepatic enzyme elevation and QT prolongation. Xenleta is indicated 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.