Public health agency the US Food and Drug Administration announced on Monday that it has approved the new antibiotic Xenleta (lefamulin) for the treatment of adults with community-acquired bacterial pneumonia under its Qualified Infectious Disease Product (QIDP) designation.
The agency granted the approval of Xenleta to Nabriva Therapeutics.
Community-acquired pneumonia occurs when someone develops pneumonia in the community (not in a hospital). Pneumonia is a type of lung infection that can range in severity from mild to severe illness and can affect people of all ages.
In conjunction, the safety and efficacy of the company's Xenleta, taken either orally or intravenously, was evaluated in two clinical trials with a total of 1,289 patients with CABP.
In both the trials, the treatment with the company's Xenleta was compared to another antibiotic, moxifloxacin with or without linezolid. The patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial