Nabriva Therapeutics plc (NASDAQ:NBRV) announced today that the European Commission (EC) has issued a legally binding decision for approval of the marketing authorization application for XENLETA™ (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults following a review by the European Medicines Agency (EMA). The EMA approval of XENLETA in CAP patients when it is considered inappropriate to use antibacterial agents that are commonly recommended for initial treatment or when these agents have failed paves the way for the launch of XENLETA across Europe. The U.S. Food and Drug Administration (FDA) approved XENLETA for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) in August 2019.
“The marketing authorization of XENLETA provides an important step forward for patients with CAP, offering the first new antibiotic class approved by the EMA in nearly two decades,” said Ted Schroeder, chief executive officer of Nabriva Therapeutics. “XENLETA has a novel mechanism of action, with targeted in vitro activity against the most common pathogens associated with CAP, and a low propensity for the development of resistance. Along with its short course, monotherapy regimen, and availability of both intravenous (IV) and oral formulations, XENLETA offers an important empiric treatment option for adult patients with CAP aligned with the core principles of antimicrobial stewardship. We believe the approval of XENLETA is a significant advancement in the fight against antimicrobial resistance and we are excited to bring this critically needed medicine to patients throughout Europe.”
The EMA approval is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants. In the two Phase 3 clinical trials, the European Medicines Agency’s co-primary endpoint was the Investigator Assessment of Clinical Response (IACR) at Test of Cure (TOC) in both the clinically evaluable (CE) and modified intent-to-treat (mITT) populations. Both studies established XENLETA to be non-inferior to the standard-of-care moxifloxacin in the treatment of adults with CAP independently and when the pooled data were analyzed across PORT scores of II-V. In the pooled analysis, the IACR success rate at TOC in the modified Intent-to-Treat (mITT) population was 85 percent in the XENLETA group and 87.1 percent in the moxifloxacin group (treatment difference ‑2.2 percent; 95 percent confidence interval (CI): ‑5.9, 1.6), and 88.5 percent in the lefamulin group and 91.8 percent in the moxifloxacin group (treatment difference ‑3.3 percent; 95 percent CI: ‑6.8, 0.1) in the clinically evaluable population. In these trials, lefamulin was generally well-tolerated. The most frequently reported adverse reactions were administration site reactions, diarrhea, nausea, vomiting, hepatic enzyme elevation, headache, hypokalemia and insomnia.