FDA announced the approval of lefamulin, which was based on the results of the LEAP 1 and LEAP 2 trials.
The United States Food and Drug Administration (FDA) has announced the approval of both the intravenous and lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adult patients (CABP).
Approval of lefamulin, which had received a priority review designation from the FDA in February, is based upon 2 phase 3 studies of more than 1200 patients with CABP.
“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. “For managing this serious disease, it is important for physicians and patients to have treatment options.”
Lefamulin, which was approved for both intravenous and oral administration, displayed its efficacy and safety profile through the LEAP 1 and LEAP 2 trials. The LEAP trials included a total of 1289 patients.
LEAP 1 examined IV to oral lefamulin compared to IV to oral moxifloxacin with or without linezolid and found lefamulin to be non-inferior when compared to moxifloxacin. LEAP 2 evaluated the efficacy of lefamulin in an intent-to-treat population 72 to 120 hours after treatment and investigators found lefamulin was non-inferior compared with moxifloxacin for early clinical response.
The most common adverse reactions reported in trial patients receiving lefamulin were diarrhea, nausea, reactions at the injections site, elevated liver enzymes, and vomiting. The FDA noted in their press release that lefamulin has the potential to cause a change on an ECG reading and patients with prolonged QT interval, with certain arrhythmias, those receiving treatments antiarrhythmic agents, and patients receiving other drugs that prolonged QT interval should avoid taking lefamulin.
The FDA’s approval of lefamulin was awarded to Nabriva Therapeutics.
“Today’s approval of XENLETA 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, chief executive officer of Nabriva Therapeutics. “We are especially proud of this approval because XENLETA was discovered in our labs over a decade ago and the entire development program was designed and executed by our dedicated and passionate team.”