Nabriva secures Xenleta FDA approval for community-acquired pneumonia

Xenleta FDA approval : Irish pharma company Nabriva Therapeutics has bagged approval from the US Food and Drug Administration for its semi-synthetic pleuromutilin antibiotic Xenleta (lefamulin) for the treatment of community-acquired bacterial pneumonia in adults.

Community-acquired pneumonia is caused when someone develops pneumonia in the community, that is not in a hospital. Pneumonia is a form of lung infection that can range in severity from mild to severe illness and can occur in people of all ages.

Xenleta has been designed to prevent the synthesis of bacterial protein, which is needed for the growth of bacteria. The binding of the pleuromutilin antibiotic happens with high affinity, high specificity and at molecular sites that are different from other antibiotic classes.

Having secured lefamulin FDA approval, Nabriva Therapeutics expects to make the new drug for community-acquired bacterial pneumonia to be available in the US through specialty distributors in mid-September 2019.

According to Nabriva Therapeutics, Xenleta will have a wholesale acquisition (WAC) price of $205 per IV patient treatment day and $275 per oral patient treatment day.

Xenleta is available in oral – 600 mg every 12 hours and IV – 150 mg every 12 hours formulations with a 5-to-7 day course of therapy.

Nabriva bags Xenleta FDA approval for community-acquired pneumonia. Photo courtesy of Nabriva Therapeutics US, Inc.

FDA comments on Xenleta FDA approval

Commenting on Xenleta FDA approval, Ed Cox – director of FDA Office of Antimicrobial Products, said: “This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease.

“For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

Basis of Xenleta FDA approval

Xenleta FDA approval was based on its safety and efficacy data assessed in two clinical trials featuring 1,289 patients with community-acquired bacterial pneumonia.

In the two clinical trials, Xenleta was compared to another antibiotic, moxifloxacin with or without linezolid. The clinical trials proved that patients treated with Xenleta had identical rates of clinical success as those who were subjected to moxifloxacin with or without linezolid.

Nabriva Therapeutics comments on Xenleta FDA approval

Ted Schroeder – CEO of Nabriva Therapeutics, commenting on Xenleta FDA approval, said: “XENLETA has a mechanism of action that is different than other approved antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes.

“XENLETA has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with CABP, which aligns with the principles of antimicrobial stewardship.”

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