CHMP recommends Fetcroja, intended for the treatment of infections due to aerobic Gram-negative organisms .- Shionogi

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fetcroja, intended for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. The applicant for this medicinal product is Shionogi B.V. Fetcroja will be available as a 1 g powder for concentrate for solution for infusion. The active substance of Fetcroja is cefiderocol, an antibacterial for systemic use (ATC code: J01DI04). It is a siderophore cephalosporin which acts by inhibiting the formation of the peptidoglycan, an important component of the bacterial cell wall. The benefits with Fetcroja are its ability to treat aerobic Gram-negative infections effectively. The most common side effects are diarrhoea, vomiting, nausea and cough.