Lefamulin NDA Filed in Mainland China for Treatment of Community Acquired Pneumonia
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, Sumitomo Pharmaceuticals’ (Suzhou) Co., Ltd., new drug application (NDA) to market oral and intravenous (IV) formulations of lefamulin for the treatment of community-acquired pneumonia (CAP) in adults in mainland China has been accepted for review by the Chinese Center for Drug Evaluation (CDE), China’s regulatory authority, on November 23, 2021.
In May 2021, Nabriva entered into an agreement for the development and commercialization rights for lefamulin in the greater China region with Sumitomo Pharmaceuticals (Suzhou), the Chinese subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Lefamulin, once approved, is expected to become a new, first in class treatment for Chinese patients with CAP.
“We are working collaboratively with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., throughout the health authority review. This filing brings Nabriva and Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. one step closer to their goal of offering lefamulin to patients with CAP in China. This is the 6th global filing for lefamulin. To date there have been 4 approvals and two applications pending review,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.
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 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. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.
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