• Xenleta (lefamulin) will be given Priority Review by FDA to act over its application in a quicker time frame.
   
• The Food and Drug Administration approved Xenleta to Nabriva Therapeutics.    

The Food and Drug Administration authorized Xenleta (lefamulin), a new antibiotic released for the treatment of community-acquired bacterial pneumonia (CABP) in adults. 

Director of FDA’s Office of Antimicrobial Products, ED Cox, M.P.H., M.D., stated that new drug released offers another option to treat patients suffering from community-acquired bacterial pneumonia, which is a serious disease. It is crucial for patients and physicians to have options for treatment for such a disease.

Cox added that this approval would reinforce FDA’s present commitment to treat infectious diseases by easily facilitating new antibiotics development.

Community-acquired pneumonia develops when an individual is infected by pneumonia in a community setting and not a hospital. Pneumonia is a kind of lung infection which can range from mild to a severe illness. It can affect people of all age groups.

Reports from Centers for Disease Control & Prevention indicate that almost one million people get hospitalized every year because of community-acquired pneumonia with about 50,000 people dying in the United States.

The efficacy and safety of Xenleta, taken intravenously or orally, was examined in 1,289 total patients with CABP. Xenleta was compared to moxifloxacin, without or with linezolid. The trials concluded that individuals treated with Xenleta had same clinical success rates as those treated with moxifloxacin without or with linezolid.

Xenleta got Qualified Infectious Disease Product (QIDP) from FDA. This QIDP designation is earned by antifungal and antibacterial drug products developed to treat life-threatening or serious infections below the Generating Antibiotic Incentives Now (GAIN) of the FDA Safety & Innovation Act. As a component of QIDP designation, the antibiotic was given Priority Review under which FDA aims to act over the application in a quicker time frame.

The Food and Drug Administration approved Xenleta to Nabriva Therapeutics.