Sinovant Sciences HK Limited today announced the submission of a New Drug Application (NDA) for Lefamulin in Hong Kong
Jan 4, 2021 Sinovant Sciences HK Limited today announced the submission of a New Drug Application (NDA) for Lefamulin for the treatment of patients with community-acquired bacterial pneumonia (CABP) to the Department of Health, Hong Kong (HK) Special Administrative Region, China. This is a significant milestone accomplished in this young company, with close collaboration from our partner Nabriva.
Once approved, patients in HK will be able to receive a brand-new class of antibiotic treatment choice after their lower respiratory system being infected with bacteria commonly found in the communities outside of the hospital. It is an essential advance in the field of anti-bacteria, where many pathogens have already developed or in the process of developing resistance with the old classes of antibiotics. Having a new class of antibiotics what is convenient to use to treat CABP is especially important at the time of COVID-19. Lefamulin is developed in both IV and oral formulation, enabling patients to be treated in various settings including inpatient and outpatient hospital settings, inpatient-to-outpatient settings, and clinics, etc.
Lefamulin is a first-in-class antibiotic for systemic administration in humans. The efficacy and safety of Lefamulin was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials against the current treatment standard moxifloxacin in a total of 1,289 patients with CABP.
Lefamulin, including both intravenous and tablet formulations, has already been approved for marketing by the U.S. Food and Drug Agency in 2019 and by the European Medicines Agency (EMA) in 2020. We look forward to bringing this product to Hong Kong patients soon.