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Find Clinical Drug Pipeline Developments & Deals by Nabriva Therapeutics
XENLETA (lefamulin) is first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow.
Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.
Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA (lefamulin) in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia.
Under the initial term of the agreement, Nabriva was solely responsible for marketing, sales, and distribution of SIVEXTRO (Tedizolid Phosphate) in the United States through December 31, 2023. The amendment extends the agreement to December 31, 2026.
XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.
Sumitomo filed NDA to market oral and IV formulations of lefamulin,first systemic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults in mainland China.
XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults, and also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone.
XENLETA® (lefamulin) is first-in-class pleuromutilin antibiotic for treatment of community-acquired bacterial pneumonia (CABP). It's in vitro activity of lefamulin against Staphylococcus aureus isolated from lower respiratory tract of children with cystic fibrosis.
Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP.
The restructured agreement provides for additional manufacturing collaboration and regulatory support [to be provided to Sinovant by Nabriva] that is expected to help expedite the delivery of XENLETA to patients in greater China.
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