FDA News

FDA approves Nabriva’s Xenleta to treat CABP in adults

Brad Spellberg
Brad Spellberg

The FDA approved Xenleta, a novel antibiotic to treat adults with community-acquired bacterial pneumonia, or CABP.

According to the drug’s manufacturer, Nabriva Therapeutics, Xenleta (lefamulin) is a first-in-class semisynthetic pleuromutilin antibiotic. It was approved in IV and oral formulations.

“It’s the first new class of antibiotic approved in nearly 20 years,” Nabriva CEO Ted Schroeder told Infectious Disease News. “The last new class of antibiotic approved for community-acquired pneumonia was in the year 2000 and one of the crying needs for antibiotics has been to discover, and bring to market, new classes of antibiotic. Xenleta is advanced in that regard.”

Two clinical trials investigated the safety and efficacy of Xenleta administered orally or intravenously to 1,289 patients with CABP. The trials found that those treated with Xenleta demonstrated similar rates of clinical success compared with patients treated with moxifloxacin with or without linezolid.

The treatment is administered orally (600 mg) or intravenously (150 mg) every 12 hours for 5 to 7 days, according to Nabriva. The wholesale acquisition price is $205 per day for the IV treatment and $275 per day for the oral treatment, the company said. It expects Xenleta to be available in mid-September 2019.

Brad Spellberg, MD, chief medical officer of the Los Angeles County-University of Southern California Medical Center and professor of clinical medicine and associate dean for clinical affairs at the USC Keck School of Medicine, was critical of the price.

“We have plenty of community-acquired pneumonia and MRSA drugs,” Spellberg told Infectious Disease News. “At $200 per day, I can’t imagine the scenario in which I would prescribe this.”

Schroeder noted that the price of Xenleta is at the lower end of branded, recently approved antibiotics. Xenleta is approved for both oral and IV administration, which allows patients to continue their therapy at home, whereas some of the older, generic antibiotics do not have a bioequivalent oral, meaning patients must be hospitalized to receive treatment, Schroeder said.

“A single extra day in the hospital is far more expensive than the total course of therapy for Xenleta,” Schroeder said. “I think that’s an important point to keep in mind.”

Spellberg said there are “numerous” cheap, safe and effective generic oral drugs for the treatment of CABP in adults that would “likely get used before a drug that costs upwards of a thousand dollars to complete a course of therapy.”

“The other issue with older, cheaper generics is of course, resistance problems,” Schroeder said. “The old generics are often not as effective, and often aren’t as safe and, ultimately, are more expensive.” – by Marley Ghizzone

Disclosures: Schroeder is employed by Nabriva Therapeutics. Spellberg reports consulting for Acurx, Alexion, Merck, Paratek, Shionogi and TheoremDx, and reports owning equity in BioAIM, ExBaq, Motif and MycoMed.

Brad Spellberg
Brad Spellberg

The FDA approved Xenleta, a novel antibiotic to treat adults with community-acquired bacterial pneumonia, or CABP.

According to the drug’s manufacturer, Nabriva Therapeutics, Xenleta (lefamulin) is a first-in-class semisynthetic pleuromutilin antibiotic. It was approved in IV and oral formulations.

“It’s the first new class of antibiotic approved in nearly 20 years,” Nabriva CEO Ted Schroeder told Infectious Disease News. “The last new class of antibiotic approved for community-acquired pneumonia was in the year 2000 and one of the crying needs for antibiotics has been to discover, and bring to market, new classes of antibiotic. Xenleta is advanced in that regard.”

Two clinical trials investigated the safety and efficacy of Xenleta administered orally or intravenously to 1,289 patients with CABP. The trials found that those treated with Xenleta demonstrated similar rates of clinical success compared with patients treated with moxifloxacin with or without linezolid.

The treatment is administered orally (600 mg) or intravenously (150 mg) every 12 hours for 5 to 7 days, according to Nabriva. The wholesale acquisition price is $205 per day for the IV treatment and $275 per day for the oral treatment, the company said. It expects Xenleta to be available in mid-September 2019.

Brad Spellberg, MD, chief medical officer of the Los Angeles County-University of Southern California Medical Center and professor of clinical medicine and associate dean for clinical affairs at the USC Keck School of Medicine, was critical of the price.

“We have plenty of community-acquired pneumonia and MRSA drugs,” Spellberg told Infectious Disease News. “At $200 per day, I can’t imagine the scenario in which I would prescribe this.”

Schroeder noted that the price of Xenleta is at the lower end of branded, recently approved antibiotics. Xenleta is approved for both oral and IV administration, which allows patients to continue their therapy at home, whereas some of the older, generic antibiotics do not have a bioequivalent oral, meaning patients must be hospitalized to receive treatment, Schroeder said.

“A single extra day in the hospital is far more expensive than the total course of therapy for Xenleta,” Schroeder said. “I think that’s an important point to keep in mind.”

Spellberg said there are “numerous” cheap, safe and effective generic oral drugs for the treatment of CABP in adults that would “likely get used before a drug that costs upwards of a thousand dollars to complete a course of therapy.”

“The other issue with older, cheaper generics is of course, resistance problems,” Schroeder said. “The old generics are often not as effective, and often aren’t as safe and, ultimately, are more expensive.” – by Marley Ghizzone

Disclosures: Schroeder is employed by Nabriva Therapeutics. Spellberg reports consulting for Acurx, Alexion, Merck, Paratek, Shionogi and TheoremDx, and reports owning equity in BioAIM, ExBaq, Motif and MycoMed.