Pharma Focus Asia

Everest Medicines Announces Acceptance of New Drug Application by China NMPA for Xerava™ for the Treatment of Complicated Intra-abdominal Infections

Monday, March 22, 2021

Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in patients in China.

Xerava™ is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class. It was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently approved for the treatment of cIAI in the US and EU.

"This marks the first NDA submission in China for Everest Medicines, representing an important step forward in our infectious disease clinical program, as well as our overall corporate mission to advance innovative and first-in-class medicines for patients in Greater China and other parts of Asia," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We remain committed to rapidly progressing clinical development of important treatments, like Xerava™ , for patients in the region and look forward to our first potential product approval in China."

In September 2020, Xerava™ was included in the Infectious Disease Society of America's (IDSA) updated clinical guidelines on the treatment of antimicrobial resistant gram-negative infections and in March 2021, it was included in an expert consensus on the multidisciplinary management of intra-abdominal infections by the Chinese Society of Surgery of Chinese Medical Association, Infectious Diseases Society for Evidence-based and Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Surgery.

Under a licensing agreement with Tetraphase Pharmaceuticals (now a wholly owned subsidiary of La Jolla Pharmaceutical Company), Everest Medicines has exclusive rights to develop and commercialize Xerava™ in Greater China, South Korea, and the key markets of South East Asia, including Indonesia, Malaysia, Philippines, Thailand, Singapore and Vietnam.

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