Nabriva’s lefamulin, BC 3781 receives FDA fast-track status to treat CABP and ABSSSI

New Drug Approvals

Nabriva’s lefamulin receives FDA fast-track status to treat CABP and ABSSS
Austria-based Nabriva Therapeutics has received qualified infectious disease product (QIDP) and fast-track status designation from the US Food and Drug Administration for its lefamulin (BC 3781).

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http://www.pharmaceutical-technology.com/news/newsnabrivas-lefamulin-receives-fda-fast-track-status-to-treat-cabp-and-absssi-4399182?WT.mc_id=DN_News

BC-3781

Topical pleuromutilin antibiotic agent

Gram-positive, including MRSA, PHASE 2 COMPLETED,Infection, acute bacterial skin and skin structure (ABSSSI)

Nabriva (Austria), Nabriva Therapeutics AG

BC-3781

cas 1061872-97-6

UNII-61H04Z5F9K

(3aS,4R,5S,6S,8R,9R,9aR,10R)-5-Hydroxy-4,6,9,10-tetramethyl-1-oxo-6-vinyldecahydro-3a,9-propanocyclopenta[8]annulen-8-yl [[(1R,2R,4R)-4-amino-2-hydroxycyclohexyl]sulfanyl]acetate;

14-O-[2-[(1R,2R,4R)-4-Amino-2-hydroxycyclohexylsulfanyl]acetyl]mutilin

BC-3781 is a pleuromutilin antibiotic in early clinical development at Nabriva for the treatment of community acquired pneumonia and for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Pleuromutilin antibiotics interfere with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit. They have a distinct antibacterial profile and show no cross-resistance with any other class of antibiotics. In 2012, a codevelopment agreement was signed between Forest and Nabriva…

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