Policy & Regulation
Sinovant Sciences wins China NMPA's approval for lefamulin CTA
14 June 2019 -

Chinese biopharmaceutical company Sinovant Sciences revealed on Thursday that its Clinical Trial Application (CTA) for lefamulin has been approved by the Center for Drug Evaluation at the National Medical Products Administration (NMPA) in China.

Following the NMPA's approval, the company will initiate registrational clinical trials for patients with community-acquired bacterial pneumonia (CABP) in the second half of 2019.

According to Sinovant Sciences, lefamulin is a novel antibiotic of the pleuromutilin class being developed as a potential treatment for CABP. Lefamulin is a semi-synthetic pleuromutilin antibiotic which works by selectively inhibiting translation of bacterial protein synthesis. Widespread use of antibiotics has created high resistance to common first line antibiotics among causative pathogens and industry estimates suggest there are as many as 18m new cases of CABP each year in China, one of the leading causes of mortality in the country.

In the company's pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that commonly cause CABP, including multi-drug resistant strains. In two global Phase 3 studies of lefamulin in patients with moderate and severe CABP, lefamulin was demonstrated to be non-inferior to moxifloxacin and met both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) primary and secondary efficacy endpoints for the treatment of CABP.

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