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FDA greenlights Nebriva’s Xenleta for community-acquired bacterial pneumonia

pharmafile | August 20, 2019 | News story | Manufacturing and Production, Sales and Marketing FDA, Nabriva, US, Xenleta, pharma, pneumonia 

The FDA has awarded approval in the US to Nebriva Therapeutics’ Xenleta (lefamulin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP), it has emerged.

The decision covers both oral and intravenous (IV) formulations of the drug, making it the first such antibiotic with a novel mechanism of action approved by the FDA in almost two decades.

The drug illustrated satisfactory efficacy in two trials encompassing 1,289 patients, compared to moxifloxacin either in combination with linezolid or alone.

“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,” explained Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We are especially proud of this approval because Xenltea was discovered in our labs over a decade ago and the entire development programme was designed and executed by our dedicated and passionate team. We are indebted to the patients and researchers who collaborated with us and are excited to bring to patients and healthcare providers a novel, short course, empiric monotherapy treatment option for CABP. 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.”

Community-acquired pneumonia refers to a form of the disease caught through the community as opposed to a hospital setting

The lung disease is the cause of around one million hospitalisations and 50,000 deaths in the US every year, according to the Centers for Disease Control and Prevention (CDC). As the median duration of a hospital stay for pneumonia patients is between three and four days, this represents a cost of $17 billion each year to healthcare providers. Around five million US patients are diagnosed each year.

Nabriva confirmed that Xenleta will be made available to patients via major US specialty distributors by mid-September.

Matt Fellows

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