FDA Accepts NDAs for Oral and IV Lefamulin for Treatment of CABP

The US Food and Drug Administration (FDA) has accepted the New Drug Applications for both the oral and intravenous (IV) formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP), Nabriva Therapeutics announced today.

Additionally, both formulations have been granted priority review, and lefamulin has been granted Qualified Infectious Disease Product and Fast Track designations by the FDA.

“We believe lefamulin has the potential to provide a much-needed monotherapy treatment option for adults with CABP,” Jennifer Schranz, MD, chief medical officer of Nabriva Therapeutics, said in a statement. “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.”

Lefamulin is a semi-synthetic pleuromutilin antibiotic that is designed to inhibit the synthesis of bacterial proteins. The drug has been evaluated in 2 phase 3 trials of patients with community-acquired pneumonia, which supported the FDA’s decision to accept both NDAs.

In the LEAP 1 trial, IV to oral lefamulin was found to be non-inferior to IV to oral moxifloxacin with or without linezolid. In LEAP 2, lefamulin again successfully met the FDA primary endpoint of non-inferiority compared with moxifloxacin for early clinical response, which was evaluated in the intent-to-treat patient population 72 to 120 hours after treatment was initiated.

“We have limited trial experience, but so far we have a drug with no food effects, good safety profile, demonstrated efficacy both IV and oral, and unique in class that will not carry the side effects that we see in fluoroquinolones and macrolides,” Thomas Lodise, PharmD, PhD, professor of pharmacy practice at Albany College of Pharmacy and Health Sciences, told Contagion® in a previous interview discussing lefamulin.

According to Nabriva, based on combined analysis of the US Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, more than 5 million adults are treated annually for CABP in the United States.

Additionally, Nabriva estimates that approximately 3 million of these adult CABP patients are diagnosed in an in-patient hospital and/or emergency department setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.

When accepting the NDAs, the FDA stated that no filing or potential review issues were identified and there are no current plans to host an advisory committee meeting to discuss the applications.

The Prescription Drug User Fee Act goal date for the completion of the FDA’s review is August 19, 2019.