FDA to Review IV, Oral Lefamulin for Community-Acquired Bacterial Pneumonia

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The FDA has accepted for Priority Review the NDA for intravenous and oral lefamulin for the treatment of CABP.

Nabriva Therapeutics announced that the Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Applications (NDA) for intravenous (IV) and oral lefamulin for the treatment of community-acquired bacterial pneumonia (CABP).

Lefamulin is a potential first-in-class, semi-synthetic pleuromutilin antibiotic. Its novel mechanism involves inhibition of synthesis of bacterial protein by binding with high specificity and affinity at molecular sites that are different than other antibiotics.

The NDA submissions included data from two phase 3 trials (LEAP 1 and LEAP 2) which evaluated IV and oral lefamulin vs moxifloxacin for the treatment of adults with CABP. In LEAP 1, patients had the option to switch from the IV to the oral route; LEAP 2 was designed to assess a short-course, 5-day oral treatment regimen.

In both studies, lefamulin proved noninferior to moxifloxacin and met the primary and secondary efficacy endpoints for the treatment of CABP. In addition, both administration routes of lefamulin were well-tolerated.

“We believe lefamulin has the potential to provide a much-needed monotherapy treatment option for adults with CABP. As demonstrated in our clinical program, the ability to switch from IV to oral administration and the short-course oral regimen has the potential to position lefamulin, if approved, as a monotherapy option for patients in the hospital, transition of care and ambulatory care settings,” stated Dr Jennifer Schranz, CMO of Nabriva Therapeutics.

The Prescription Drug User Fee Act (PDUFA) target date for both NDAs has been set for August 19, 2019.

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