Nabriva Therapeutics Gets FDA Approval for New Bacterial Pneumonia Drug

Drug-resistant bacteria is quickly becoming the scourge of this generation, an unfortunate development that could become quite a dangerous epidemic.  As such, medical scientists continue to work on new treatments that will be effective as this problem grows.  Fortunately, it appears we are already making some headway in this field. 

At the top of the week, the United States Food and Drug Administration approved a community-acquired bacterial-pneumonia treatment (CABP) from Nabriva Therapeutics.  The drug is called lefamulin (to be sold under the brand name Xenleta) and it is hopefully just the first in a brand new class of antibiotics—pleuromutilins–that target a different protein synthesis binding site than older versions of similar treatments. 

Xenleta has been approved for both oral and intravenous. This should make it more accessible to the approximately 5 million Americans affected by CABP every year. The Irish drugmaker behind the treatment, though, adds that the novelty of this drug will also help to further educate physicians, hospitals, and insurance companies on its efficacy.  Of course, the hope is also that observation of its efficacy will justify its price of $205 per IV patient treatment day and $275 per oral patient treatment day, for a duration of up to 7 days.

After two years of development and trials, then, today’s approval is a “significant breakthrough in the collective fight against the growing threat of antimicrobial resistance,” according to Nabriva Therapeutics chief executive officer Ted Schroeder.  He goes on to say that this treatment will provide a desperately needed empiric monotherapy treatment option for adults with CABP.  

Schroeder reminds that this announcement is particularly special because Xenleta was originally discovered in their laboratory ten years ago.  Since then, they have been working intimately and feverishly to bring it to the public, and to be able to release it such a time when it is so needed is rewarding. 

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