May 29, 2020 at 8:00 AM EDT
- 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 Europe
- CHMP opinion supported by robust safety and efficacy data from two global pivotal Phase 3 trials of XENLETA
- European Commission decision anticipated in the second half of 2020
DUBLIN, Ireland, May 29, 2020 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of XENLETA (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. The CHMP opinion will be reviewed by the European Commission (EC), which has the authority to approve medicines for all 28 countries of the European Union, Norway, Iceland, and Liechtenstein. A regulatory decision is anticipated during 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 Europe in almost 20 years,” said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. “XENLETA has a novel mechanism of action and provides an urgently needed short course, empiric monotherapy treatment alternative for adult patients with CAP. We look forward to the European Commission’s decision and the opportunity to bring this important medicine to patients.”
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.
The European Commission will review the CHMP recommendation and typically delivers its final decision in approximately two months. The U.S. Food and Drug Administration (FDA) approved XENLETA in August 2019 for the treatment of adult patients with community-acquired bacterial pneumonia (CABP).
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