Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today 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).
"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 approved by the National Medical Products Administration ("NMPA") of China in March 2023 and commercially launched in July. It has also been approved and commercialized in Singapore. XERAVA® has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency 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).
About XERAVA® (eravacycline)
XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative, Gram-positive and anaerobic pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK, Singapore, mainland China, Hong Kong, and Taiwan. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases,
