Sinovant’s partner Nabriva Therapeutics Receives U.S. FDA Approval of Lefamulin to Treat Community-Acquired Bacteria Pneumonia (CABP)
First New IV and Oral Antibiotic with a Novel Mechanism of Action Approved in Nearly Two Decades Provides Critically Needed Treatment Option for Adult Patients with CABP
Aug. 19, 2019 – Sinovant’s partner Nabriva Therapeutics plc (NASDAQ: NBRV), announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) in adults. As the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades, lefamulin represents an important new empiric monotherapy treatment option for adults with CABP.
Both the IV and oral formulations of lefamulin were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA. The FDA approval was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 trials (known as LEAP 1 and LEAP 2). Both trials showed comparable efficacy with moxifloxacin and generally well tolerated safety.
CABP is one of the common infectious disease threatening public health. 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 18 million new cases of CABP each year in China1,2. “With the growing threat of antimicrobial resistance,” said Dr. Rae Yuan, President of Sinovant. “it is urgent to develop a new antibiotic with high targeted spectrum of activity, novel mechanism of action, low propensity for the development of resistance and cross-resistance and convenience for clinical use, so as to provide new and effective treatment for CABP.
Sinovant Sciences has an exclusive license to develop and commercialize lefamulin (SNV001) in Greater China region. The Chinese clinical trial application is approved by the National Medical Products Administration, and expected to be initiated on Q4 2019.
“We are thrilled about Lefamulin's approval in the United States!” said Dr. Xinan Chen, Executive Chairman of Sinovant. “We look forward to bringing this fist-in-class innovative product to China as soon as possible, to connect Chinese patients with the benefit of global drug innovation.”
Sinovant Sciences is an innovative biopharmaceutical company based in Shanghai, China Sinovant is uniquely positioned to bring cutting-edge global medical innovation to China, and transformative Chinese medical innovation to the world.
1Pereyre S et al. Front Microbiol 2016; 7:974
2Leerink Partners research