XENLETA (lefamulin) Receives Health Canada Approval for Treatment of Community Acquired Pneumonia

-XENLETA to be marketed exclusively in Canada by Sunovion Pharmaceuticals Canada Inc.

DUBLIN, Ireland, July 16, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that its partner, Sunovion Pharmaceuticals Canada Inc., has received approval from Health Canada to market oral and intravenous (IV) formulations of XENLETA (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults. Additional information on the Notice of Compliance from Health Canada dated July 10, 2020 is available at https://health-products.canada.ca/noc-ac/info.do?lang=en&no=23888. 

Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc. 

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).  XENLETA was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com.

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 are administration site reactions (7%), diarrhea (7%), nausea (4%), vomiting (2%), hepatic enzyme elevation (2%), headache (1%), hypokalemia (1%), and insomnia (1%). Administration site reactions led to discontinuation in <1%; gastrointestinal disorders were predominantly associated with the oral formulation and led to treatment discontinuation in <1%.