NDAs Submitted for Oral, IV Formulations of Lefamulin for CABP
Lefamulin is a first-in-class, semi-synthetic pleuromutilin antibiotic.
Nabriva Therapeutics announced the submission of two New Drug Applications (NDAs) to the Food and Drug Administration (FDA) for the oral and intravenous (IV) formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP).
Lefamulin is a first-in-class, semi-synthetic pleuromutilin antibiotic designed to inhibit the synthesis of bacterial protein by binding with high affinity, high specificity and at molecular sites that are different than other antibiotic classes.
The NDA submissions included data from two Phase 3 trials (LEAP 1 and LEAP 2) which evaluated the safety and efficacy of IV and oral lefamulin vs moxifloxacin in the treatment of adults with CABP, including the option to switch from IV to oral administration and a short course oral treatment with lefamulin. In both trials, lefamulin demonstrated noninferiority to moxifloxacin and met the primary and secondary endpoints for the treatment of CABP. Lefamulin was well tolerated among study patients when given orally or by IV infusion.
Both oral and IV formulations were granted Qualified Infectious Disease Product and Fast Track designations by the FDA. In a press release, the Company stated, " [...] lefamulin is well-positioned for use as a first-line monotherapy for the treatment of CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated safety profile."
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