The US Food and Drug Administration said that it had approved Nabriva Therapeutics’ antibiotic Xenleta for treating patients with community-acquired pneumonia.
The drug, also called lefamulin, works by interfering with the bacteria’s ability to replicate and has been approved in both injectable (IV) and oral forms.
The drug is also Nabriva’s first to be approved by the FDA and is expected to be launched in mid-September.
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.
Nabriva estimates about 5 million to 6 million Americans are diagnosed with community-acquired bacterial pneumonia every year, making it a leading cause of infectious deaths and hospitalization in the United States.
Shares of the company were down 3 percent before being halted in late afternoon trading
Pneumonia is generally treated with antibiotics such as moxifloxacin or levofloxacin, many of which have become ineffective as bacteria become resistant to the commonly prescribed treatments.
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.