Posted from: Thursday, September 19, 2019 - 09:50 AM - Present

Xenleta Approved to Treat Pneumonia

August 19, 2019 – The U.S. FDA has approved Xenleta™ (lefamulin), manufactured by Nabriva Therapeutics, to treat community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms in adult patients. It is the first in a new class of antibiotics known as pleuromutilins.

Community-acquired pneumonia (CAP) is pneumonia contracted outside of a hospital or other healthcare setting and can be caused by bacteria, viruses, parasites, and fungi. It is a leading cause of morbidity and mortality worldwide, and responsible for hospitalizing 1.5 million adults in the United States annually. One out of every three adults hospitalized with CAP will die within one year. CAP also accounts for over 4.5 million outpatient and emergency room visits annually.

In a clinical study, Xenleta demonstrated comparable efficacy with moxifloxacin, a current standard of treatment for CABP, with two fewer days of therapy. The product can be administered orally at a recommended dose of one 600mg tablet taken every 12 hours, or via intravenous (IV) infusion at a recommended dose of 150mg every 12 hours. Therapy should run from five to seven days. If appropriate, prescribers can initiate patients on the oral dosage form, which may help prevent a hospital stay. Prescribers can also transition from the IV dosage form to oral tablets to allow patients to continue treatment at home and facilitate an earlier discharge from the hospital.

Nabriva plans to launch Xenleta in September 2019 at a wholesale acquisition cost (WAC) of $205 per IV patient treatment day and $275 per oral patient treatment day.

Last Updated Friday, October 18, 2019 - 12:30 AM.