August 19, 2019
To read more about the recent drug approval, click here.
By Saumya Joseph
(Reuters) - Nabriva Therapeutics Plc on Monday priced an oral and injectable version of its antibiotic Xenleta, which treats community-acquired pneumonia, at more than $200 per day after it received approval from the U.S. Food and Drug Administration.
The drug, also called lefamulin, works by interfering with the bacteria's ability to replicate. It's the first drug by the company to be approved by the FDA and is expected to launch in mid-September.
The company said the injectable would have a list price of $205 per day, and the oral version would be $275 per day. However, the list price is not necessarily what patients actually pay as "out-of-pocket" costs vary based on the duration of the treatment and individual healthcare plans.
Although a number of patients reported side effects such as diarrhea and vomiting during the drug trial, the company said the effects were well within the range of other antibiotics taken orally.
The safety and efficacy of Xenleta was evaluated in two clinical trials with a total of 1,289 patients. Treatment with Xenleta was compared to treatment with moxifloxacin with or without linezolid. Patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.
In April, the FDA declined to approve the company's other antibiotic Contepo for urinary tract infections, citing manufacturing deficiencies at a contract manufacturer. Nabriva on Friday said it would re-apply for FDA approval early in the fourth quarter of 2019.
"Lefamulin is a bigger opportunity than Contepo. But we still don't think Contepo is dead ... there's just a little delay going on there with the FDA," Wedbush analyst Robert Driscoll said ahead of the decision.
Driscoll expects Xenleta to initially struggle as it penetrates the market and expects the drug to bring in peak sales of $267 million by the end of 2025.
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