Nabriva scores its first FDA nod with novel antibiotic Xenleta

Xenleta (lefamulin)
The FDA approved Nabriva's Xenleta Monday to treat community-acquired bacterial pneumonia. (Nabriva)

With drug-resistant bacteria on the rise, antibiotics have struggled to keep up with the challenge. Now, with the FDA’s approval of a new antibiotic for bacterial pneumonia, some of that may change. 

Monday, the FDA approved Nabriva Therapeutics’ Xenleta (lefamulin) to treat community-acquired bacterial-pneumonia (CABP) as the first in a new class of antibiotics called pleuromutilins, which target a different protein synthesis binding site than older competitors.

Nabriva will market Xenleta, approved in both an oral and intravenous formulation, as a new answer for CABP, which affects around 5 million Americans each year, the Irish drugmaker said. But with the drug’s novelty, Nabriva will be tasked with educating physicians, hospitals and payers on its efficacy.

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According to CEO Ted Schroeder, that process is already underway.

RELATED: Nabriva lines up FDA filing after antibiotic clears second pivotal test

For two years, Nabriva has been rolling out a team of medical science liaisons focused on interacting with physicians and assessing clinical needs. Along with market access teams working with payers and distributors and another team focused on creating a “patient profile” for the drug, Schroeder said Nabriva has set the foundation for an expected sales force of 60 to hit the ground running. Schroeder said Xenleta is scheduled to launch in September.

“That’s a lot of preparation work that most other companies haven’t done,” Schroeder said.

Part of Xenleta's sales pitch off the bat will be its dual formulation for both oral and IV use, which Schroeder said would allow physicians to get their patients out of the hospital faster and potentially open the drug up for outpatient marketing down the line.

“Over time, as physicians get comfortable with the product, we believe that community-based physicians will prescribe the oral form right from the” beginning, Schroeder said. “We will have all the bits and pieces in place for a patient to have a prescription available in the outpatient setting.”

Xenleta's approval will catapult Nabriva from a clinical-stage biotech into a commercial enterprise, but the drugmaker still has work to do to get a separate antibiotic approved after an FDA setback.

RELATED: Nabriva's new antibiotic rejected by FDA over issues at EU contractor

Last week, Nabriva said it planned to resubmit its NDA for Contepo (fosfomycin) in the fourth quarter after the drug’s contract manufacturer was cited for “inspectional” deficiencies by the FDA in April. Schroeder said the drug’s Complete Response Letter didn’t call the antibiotic’s safety or efficacy into question and that the issues cited in the letter had been corrected.

If Contepo is eventually approved, it will complete Nabriva’s transformation into a full-blown pharma, and Schroeder, a former CEO of Zavante Therapeutics and the founder of Cadence Pharmaceuticals, said that cultural change will present challenges for the drugmaker after years at the clinical stage.

“It’s always a challenge—it’s a rare thing to bring a product from birth all the way to approval,” he said. “The good news is we have a team of people that have been through this before. An awful lot of it is people are clear on role and understand what everyone does.”

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