Posted by Michael Wonder on 21 Feb 2019
Nabriva Therapeutics announces acceptance of new drug applications by the FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
19 February 2019 - PDUFA action date set for August 19, 2019.
Nabriva Therapeutics announced that the U.S. FDA has accepted the New Drug Applications (NDAs) and granted a priority review for both the intravenous and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia.
The acceptance of lefamulin’s two applications indicates that the FDA has deemed both applications sufficiently complete to allow a substantive review. Both applications have been granted priority review and the Prescription Drug User Fee Act goal date for the completion of the FDA’s review is 19 August 2019.
In addition to priority review, lefamulin has been granted qualified infectious disease product and fast track designations by the FDA.
