NABRIVA Receives European Approval for XENLETA® (lefamulin) for Treatment of Community-Acquired Pneumonia (CAP)

XENLETA represents the first new antibiotic class approved for patients with CAP in Europe in nearly 20 years

-XENLETA approval provides urgently needed short-course, empiric monotherapy treatment option for CAP aligned with core principles of antimicrobial stewardship

DUBLIN, Ireland I July 28, 2020 I 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.

About CAP

Approximately three to four million cases of pneumonia occur annually in the EU (Gibson et al, 2013). Data from the Global Burden of Disease 2015 Study reported that lower respiratory tract infections, including pneumonia, were the third most common cause of death worldwide and the most common cause of infectious death globally, claiming three million lives annually (GBD, 2016; WHO, 2018). The impact on morbidity and mortality associated with community-acquired pneumonia is magnified in older patients, where data have shown that mortality is associated with advancing age (Welte et al, 2012; Cillóniz et al, 2013; Ochoa-Gondar et al, 2008). Approximately 90 percent of deaths due to pneumonia occur in people over 65 years old (EC, 2009a).

About Nabriva Therapeutics

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.

About XENLETA

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 were 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% of patients; gastrointestinal disorders were predominantly associated with the oral formulation and led to treatment discontinuation in <1% of patients.

For more information about Xenleta please refer to the Summary of Product Characteristics [SmPc] at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xenleta

SOURCE: Nabriva Therapeutics

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