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On July 28, local time, Nabriva Therapeutics announced that the European Commission (EC) had officially approved its innovative antibiotic Xenleta (lefamulin) for adult patients with community-acquired pneumonia (CAP).
said it was the first new antibiotic approved in Europe in nearly 20 years, providing an important treatment option for CAP patients.
Xenleta, discovered and developed by Nabriva, is the first of its kind to be created with a class of pleuromutilin antibiotics.
inhibits bacterial protein synthesis by combining with the peptide transferase center (PTC) of bacterial kerucleosomes, thus achieving the effect of inhibiting bacterial growth.
the drug's binding target to bacteria is different from other antibiotics, and this particular combination has a high degree of affinity and specificity.
given this novel mechanism of action, it is less likely to induce drug resistance.
In August 2019, Xenleta was approved by the FDA for community-based bacterial pneumonia (CABP), the first FDA-approved antibiotic with an innovative mechanism in nearly 20 years.
EU approval of Xenleta is based on positive efficacy data from two key Phase 3 clinical trials (LEAP 1, LEAP 2) and safety data from 1,242 patients.
LEAP 1, LEAP 2 study evaluated the efficacy and safety of intravenous and oral Xenleta relative to the treatment of CABP adult patients with moxifloxacin, with a total of 1,289 patients participating in the trial.
two studies, Xenleta has been shown to be non-inferior to Moxiza and to be consistent with the FDA and the European Medicines Agency (EMA) for the treatment of CABP at the primary and secondary therapeutic endpoints.
common primary endpoint of the EMA was the clinical response (IACR) evaluated by the researchers during treatment visits (TOCs) in both trials and in the improved treatment intent (mITT) group.
in the summary analysis, the success rate of IAC at TOC in the mITT population was 85% in the Xenleta treatment group and 87.1% in the Moxiza star group (treatment difference -2.2%, 95% CI:-5.9, 1.6).
among all clinically assessable populations, the success rate was 88.5% in the Xenleta group and 91.8% in the Moxiza star group (treatment difference -3.3%; 95% CI: -6.8, 0.1).
studies, both intravenous and oral Xenleta showed good tolerance.
the world's third most common cause of death, including pneumonia, and the world's most common cause of infectious death, claiming 3 million lives each year, according to the Global Burden of Disease Study 2015.
in older patients, CAP-related morbidity and mortality are associated with age, with data showing that about 90 percent of pneumonia deaths occur in people over 65.
in the European Union, there are about three to four million cases of pneumonia each year.
source: NABRIVA Receives European Approval for XENLETA ® For Treatment of Community-Acquired Pneumonia (CAP)