FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia

The FDA has approved Lefamulin (Xenleta, Nabriva) for the treatment of adults with community-acquired bacterial pneumonia (CABP). 

Lefamulin is a first-in-class, semi-synthetic pleuromutilin antibiotic that inhibits the synthesis of a bacterial protein required for growth. According to a release from Nabriva, the product binds with a high affinity and high specificities at molecular sites that are different than other antibiotic classes. 

“Today’s approval of lefamulin is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,” said Ted Schroeder, CEOof Nabriva Therapeutics in a statement. Lefamulin has a mechanism of action that is different than other approved antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes. Lefamulin has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with CABP, which aligns with the principles of antimicrobial stewardship.”

Lefamulin is available as IV and oral administration. Lefamulin is specifically indicated to treat CABP caused by any of the following bacteria: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae,Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

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“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products, in an FDA statement. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

Lefamulin is contraindicated in patients with a known hypersensitivity to lefamulin or pleuromutilins, and those using CYP3A substrates that prolong the QT interval. 

Safety warnings are issued for patients with known QT prolongation, ventricular arrhythmias, and those receiving drugs that may prolong the QT interval. Lefamulin may case fetal harm, and Clostridium difficile-associated diarrhea (as is reported with nearly all systemic antibacterial agents). 

Adverse reactions for the IV version of lefamulin include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache.

Adverse reactions for the oral tablet version of lefamulin include diarrhea, nausea, vomiting, and hepatic enzyme elevation.