With results from the first Phase III study of its antibiotic lefamulin in community-acquired bacterial pneumonia now under its belt and a second pivotal study due to report in the spring of 2018, Nabriva Therapeutics AG is gearing up for a regulatory filing in the US.
Nabriva announced Sept. 18 that in the LEAP 1 study, lefamulin met the primary endpoint of non-inferiority for early clinical response against standard-of-care treatment of moxifloxacin, a fluoroquinolone, with or without adjunctive treatment with Pfizer Inc
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