Sumitomo's Xenleta approved in China
Japanese drugmaker Sumitomo Pharma (TYO: 4506) has received approval from China’s National Medical Products Administration (NMPA) for the use of Xenleta (lefamulin acetate) to treat adults with community-acquired pneumonia in injection and tablet formulation.
Xenleta is a pleuromutilin antimicrobial agent discovered and developed by Sandoz spin-out Nabriva Therapeutics (OTCMKTS: NBRVF). The drug’s entire development program was designed and executed by the Ireland-based infectious diseases specialist, which has since closed down, becoming the latest antibiotic developer to fail commercially.
The product was initially in-licensed and then acquired by Sumitomo in the geographies of China, Taiwan, Hong Kong, and Macau.
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