Drug Info

FDA approves Xenleta to treat bacterial pneumonia

By | August 20, 2019

On Monday, the U.S. Food and Drug Administration (FDA) announced its approval of two formulations of Xenleta (lefamulin)—oral and intravenous—to treat community-acquired bacterial pneumonia (CABP) in adults. 

Nabriva Therapeutics—a biopharmaceutical company that specializes in the development of anti-infective agents that treat serious infections—developed Xenleta more than 10 years ago. It’s designed for two purposes: 

  • to treat adults infected with pneumonia outside the hospital setting, and 
  • to combat antimicrobial resistance to drugs that are already on the market. 

Meaning, Xenleta is capable of preventing nasty bacterial infections (like CAPB) from mutating and becoming resistant to treatment. This is an important breakthrough as resistant bacteria, or “Superbugs,” that are invulnerable to most common antibiotics become more and more common. “Superbugs” that cause pneumonia, urinary tract infections, and skin infections are some of the more dangerous mutations of bacterial infections we face today.

Xenleta can potentially change that. The medication works by inhibiting the synthesis of bacterial protein, which is necessary for bacteria to be able to grow and change.

“Today’s approval of Xenleta is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,” Ted Schroeder, chief executive officer of Nabriva Therapeutics, said in a press conference.

Julio Ramirez, MD, professor of medicine and chief within the Division of Infectious Diseases at University of Louisville School of Medicine, added in a press release: “As an infectious disease specialist who treats CABP patients in the hospital setting, I am grateful to have both a new IV and oral option that gives me confidence that my patients will continue to receive appropriate therapy once they are discharged from the hospital.”

Pneumonia is behind 257,000 trips to the ER every year, according to the Centers for Disease Control and Prevention. Additionally, it causes nearly 50,000 deaths annually. The hope is that treatments such as Xenleta can significantly drive these numbers down.

According to Nabriva, Xenleta will be available through major U.S. specialty distributors by mid-September 2019. The medication will have a wholesale acquisition (WAC) price of $205 per IV patient treatment day and $275 per oral patient treatment day. Cash pay prices and the costs for patients with insurance will be determined closer to the drug’s release.