Nabriva’s XENLETA Demonstrates High Efficacy in Patients of Advanced Age with Community-Acquired Bacterial Pneumonia (CABP)
-- Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes --
-- Pooled analysis of data by age group from pivotal LEAP 1 and LEAP 2 Phase 3 clinical trials to be presented at CHEST Annual Meeting 2020 --
“People of advanced age are especially at risk for developing CABP as a result of a weakened immune system and age-related comorbidities that increases the chances of hospitalization and CABP-related complications leading to functional impairment and/or mortality,” said
In this pooled analysis of 1289 patients from LEAP 1 and LEAP 2 by age group, including adults ages 18-64, 65-74, 75-84, and 85 and older, 40 percent of the overall pooled patient population was over 65 years of age. Compared to younger patients, patients 65 years of age and older had higher pneumonia severity scores and were more likely to have renal impairment, cardiac disease, hypertension, diabetes or asthma/COPD. The analysis showed that early clinical response (ECR) and investigator assessment of clinical response (IACR) at the Test of Cure (TOC) for XENLETA were high (approximately 90%) and similar to that of moxifloxacin, a current standard of care fluoroquinolone for CABP, for all age groups. The adverse event profile and study drug discontinuation rates were similar across all age groups.
XENLETA is a first-in-class systemic pleuromutilin antibiotic with a unique mechanism of action that attacks the difficult-to-treat pathogens in CABP and addresses the challenges of antibiotic resistance. It is approved by the FDA for the IV and oral treatment of CABP in adults. Full results of the pooled analyses presented at the virtual CHEST Annual Meeting can be found here: https://www.nabriva.com/Portals/0/Nabriva/Posters/CHEST2020/LEF3067_CHEST%202020%20ePoster_LEAP%201%202%20Efficacy%20Safety%20by%20Age.pdf
Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for 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 common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.xenleta.com.
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
INDICATION AND IMPORTANT SAFETY INFORMATION
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.
Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Clostridium-difficile associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact
Please see Full Prescribing Information for XENLETA.
Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major
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Source: Nabriva Therapeutics US, Inc