Sinovant Sciences HK Limited announced today the submission of a New Drug Application (NDA) for Lefamulin for the treatment of patients with CABP in Taiwan


Jan 5, 2021    Sinovant Sciences HK Limited announced today the submission of a New Drug Application (NDA) for Lefamulin for the treatment of patients with community-acquired bacterial pneumonia (CABP) in Taiwan. The second NDA was submitted for this drug in Greater China by Sinovant.

 

Lefamulin is the first human systematic drug in a new class of antibiotics, pleuromutilin. It is active against a wide spectrum of common pathogens found in the respiratory system (including gram-positive, gram-negative, and atypical pathogens). The results of in vitro experiments showed that Lefamulin has low propensity for development of bacterial resistance and cross-resistance due to the multiple binding sites on the bacterial ribosome.

 

The efficacy and safety of lefamulin compared with the current standard of care, moxifloxacin was demonstrated in a total of 1,289 patients with CABP in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials. Lefamulin, including intravenous and tablet formulations, was approved for marketing by the U.S. Food and Drug Administration (FDA) in 2019 and by the European Medicines Agency (EMA) in 2020. These formulations offer the possibility of treating diseases in various settings, including hospital inpatient, outpatient, inpatient-to-outpatient settings, and community clinics, etc. and can better cope with the treatment needs caused by COVID-19.