At its February meeting, the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended two antibacterial agents: cefiderocol and a generic version of tigecycline.
Cefiderocol (Fetcroja, Shionogi BV) is for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
Cefiderocol is a siderophore cephalosporin that inhibits formation of peptidoglycan, a key component of the bacterial cell wall. It will be available as a 1-g powder for concentrate for solution for infusion.
Cefiderocol has been shown to "effectively" treat aerobic Gram-negative infections, the EMA said in summary statement. The most common side effects with cefiderocol are diarrhea, vomiting, nausea, and cough.
The CHMP also recommended marketing authorization for a generic version of tigecycline (Tigecycline Accord, Accord Healthcare) for adults and children as young as age 8 years with complicated skin and soft tissue infections (excluding diabetic foot infections) and complicated intra-abdominal infections.
Tigecycline Accord is a generic of Tygacil, which has been on the market in the European Union since 2006.
"Studies have demonstrated the satisfactory quality of Tigecycline Accord. Since Tigecycline Accord is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Tygacil was not required," the EMA said in a summary statement.
Tigecycline Accord should be used only in cases in which other alternative antibiotics are not suitable, the EMA said.
The agency recommends that both cefiderocol and generic tigecycline be prescribed by physicians experienced in the management of infectious diseases.
Detailed recommendations for the use of these drugs will be included in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.
Cite this: EMA Panel Backs Two Antibacterials, Cefiderocol and Generic Tigecycline - Medscape - Mar 02, 2020.