FDA accepts 2 new drug applications for lefamulin intravenous and oral preparations for the treatment of CABP

recently, NabrivaTherapeutics(http:// announcedthat the U.SFood andDrug(http://Administration
(http://has accepted two applications fornew drug(http://(NDA) in the community of lefamulin intravenous and oral preparations to treat the community of obtained bacterial pneumonia (HTTP://WWW.CHEMDRUG.COM/) and granted priority review spending on prescription drug prescription severance (p)about lefamulin
lefamulin is a potentially first-of-the-
, system-
synthetic (http:// shorter side earin (http:// antibiotic that inhibits the synthesis of bacterial proteins, binds with a high degree of affinity and specificity, and occurs in molecular locations different from other antibiotic classes In addition to priority reviews, the FDA has previously granted lefamulin qualified infectious disease product (http:// (QIDP) and fast-track eligibility 　　These two NDAs are supported by data from two critical Phase III clinical studies (LEAP-1, LEAP-2) These two studies assessed the efficacy and safety of intravenous and oral formulations, lefamulin, in treating adult patients with CABP compared to moxifloxacin THE LEAP-1 STUDY WAS DESIGNED TO CHOOSE FROM AN INTRAVENOUS PREPARATION TO AN ORAL PREPARATION, AND THE LEAP-2 STUDY WAS DESIGNED AS A SHORT COURSE OF ORAL LEFAMULIN FOR 5 DAYS In both studies, lefamulin was found to be not inferior to moxisastar and met the primary and secondary efficacy endpoints of the FDA and EMA treatment of CABP in studies, both lefamulin intravenous and oral preparations showed good tolerance