Nabriva Therapeutics Receives Positive EU CHMP Opinion for XENLETA™ (lefamulin) for the Treatment of Community-Acquired Pneumonia (CAP)
- If approved, XENLETA has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous (IV) and oral treatment of adult patients with CAP in
- CHMP opinion supported by robust safety and efficacy data from two global pivotal Phase 3 trials of XENLETA
European Commissiondecision anticipated in the second half of 2020
“Today’s announcement brings us one step closer to the first approval of a new class of antibiotics for patients with community-acquired pneumonia in
The CHMP recommendation for marketing authorization 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 EMA 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 are administration site reactions, diarrhea, nausea, vomiting, hepatic enzyme elevation, headache, hypokalemia, and insomnia.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most frequently reported adverse reactions are administration site reactions (7%), diarrhea (7%), nausea (4%), vomiting (2%), hepatic enzyme elevation (2%), headache (1%), hypokalaemia (1%), and insomnia (1%). Administration site reactions led to discontinuation in <1%; gastrointestinal disorders were predominantly associated with the oral formulation and led to treatment discontinuation in <1%.
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Nabriva Therapeutics plc
Source: Nabriva Therapeutics US, Inc