May 21, 2018 / 11:56 AM / Updated an hour ago

Nabriva's pneumonia drug succeeds in late-stage study

(Reuters) - Nabriva Therapeutics Plc’s pneumonia drug for adults met the main goal of a late-stage study, the company said on Monday, putting it on track to file a marketing application with U.S. regulators later this year.

The drug, lefamulin, is Nabriva’s lead treatment, and the study showed it was not inferior to an existing antibiotic in treating patients with a moderate community-acquired bacterial pneumonia (CABP).

Pneumonia is the leading cause of infection-related deaths in the United States, and the second leading cause of hospitalizations in the country, Nabriva said.

The company plans to submit a marketing application with the U.S. Food and Drug Administration in the fourth quarter of the year.

Lefamulin already succeeded in another late-stage study in CABP patients last September.

Shares of Nabriva were halted in premarket trading on Monday are expected to resume trading around 8 a.m. Eastern Time.

Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar