NABRIVA Receives European Approval for XENLETA (lefamulin) for Treatment of Community-Acquired Pneumonia (CAP) - Seite 2

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.