Nabriva receives FDA approval for novel antibiotic

Nabriva receives FDA approval for novel antibiotic

  • 21/08/2019

Nabriva Therapeutics plc has got the go from the FDA to market its pleuromutilin antibiotic Xenleta (lefamulin), a protein synthesis blocker with new mode-of-action to treat community-acquired bacterial pneumonia.

The drug, which will be offered both for intravenous and for oral administration, blocks the peptidyl transferase domain of the ribosome. The drug has also fast track status to treat acute bacterial skin and skin structure infections. Nabriva intends to price the intravenous formulation at $205 per day and the oral drug at $270 per day.

The company puts its hopes on updates to CMS reimbursement policies for novel antibiotics. On August 2, 2019, the US government agency that administrates Medicare & Medicaid (CMS) announced several significant changes to hospital antibiotic reimbursement, effective October 1, 2019. In brief, the IPPS FY2020 Final Rule defines rules for reimbursing new in-hospital antibiotics when they are needed, it proposes a way to recognize the overall cost of managing drug-resistant infections, and is the most significant pull incentive for antibiotics that ever seen. The new rule also includes payments for managing the complexity of drug-resistant infections. In parallel, CMS highlighted the need to pair these incentives with antibiotic stewardship, promising action on the long-anticipated CMS antibiotic stewardship rule.

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