Everest Medicines Bags TFDA Approval To Treat Intra-abdominal Infections

Everest Medicines, a biopharmaceutical company focused on the development, manufacturing, and commercialization of novel medicines and vaccines, announced that the Taiwan Food and Drug Administration (TFDA) has approved the New Drug Application(NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adults.

“The NDA approval of Xerava in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal infections and other life-threatening infections to more patients in Asia,” said Rogers Yongqing Luo, chief executive officer of Everest Medicines. “Following the successful commercial launch of Xerava in mainland China and Singapore, we will accelerate patient access to this product in more markets including Hong Kong and Taiwan.” Xerava was authorized by China's National Medical Products Administration (NMPA) in March 2023 and went on sale in July. Singapore has also approved and marketed it. Multiple treatment guidelines in China and throughout the world have suggested Xerava because to its broad bacterial spectrum coverage and great efficacy against multidrug-resistant bacterial infections.

Everest entered into an exclusive partnership agreement with TTY Biopharm (TTY) in 2022 for commercialization of Xerava in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin), as per pharmabiz.

Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum fluorocycline parenteral antibiotic of the tetracycline class that has demonstrated broad in vitro activity against Gram-negative, Gram-positive, and anaerobic pathogens with multidrug resistance (MDR) that are common in China. Xerava is now licensed for the treatment of complex intra-abdominal infections (cIAI) in the United States, the European Union, the United Kingdom, Singapore, mainland China, Hong Kong, and Taiwan.