Nabriva Therapeutics PLC (NBRVF)

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FDA's decision looming on Nabriva's experimental antibiotic

Nabriva's new drug application for its Contepo antibiotic is being reviewed by the FDA.
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By John George – Senior Reporter, Philadelphia Business Journal
2 hours ago
The Food and Drug Administration is expected to make a decision this week on a new application filed by Nabriva Therapeutics for what the company describes as “the first truly new antibiotic in nearly two decades."

Nabriva is seeking approval for Contepo as a treatment for complicated urinary tract infection still

The two conditions combined afflict 8 million to 9 million patients annually in the United States, according to Nabriva.

The FDA is scheduled to rule on the company's Contepo application by the end of the day on April 30.

Contepo and Lefamulin, according to company officials, are designed to kill bacteria in a different way than other recently approved antibiotics.

“Doctors and their patients are in significant need of new treatment options,” Schroeder said. “A growing number of bacterial and fungal infections have become resistant to currently available antibiotics, creating an urgent need for new antibiotics that work in different ways. If approved by the FDA, Contepo will be the first novel intravenous antibiotic to be introduced in the U.S. in nearly two decades for the treatment of (complicated urinary tract infections).”

Schroeder said Narbriva, which has grown to 110 employees, has assembled an experienced executive and commercial team with extensive backgrounds in the development and commercialization of antimicrobial and hospital medicine. “We have also invested in the expertise of a medical science liaison team to spearhead scientific and patient community education and awareness,” he said. “We plan to expand our workforce in a focused and targeted manner with approximately 60 sales representatives in the field” should Contepo receive FDA approval.

Nabriva developed Lefamulin internally and acquired the rights to Contepo last year as part of its purchase of San Diego-based Zavante Therapeutics in a deal valued at up to $124.5 million.