The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended to the European Commission than an EU licence be granted to Fetcroja (cefiderocol) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
The active substance cefiderocol is a siderophore cephalosporin which acts by inhibiting the formation of peptidoglycan for the bacterial cell wall.
The most common side effects seen with Fetcroja are diarrhoea, vomiting, nausea and cough.
Fetcroja will be available as a 1g powder for concentrate for solution for infusion. The full indication is the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. It is proposed that the medicine be prescribed only after consultation with a physician with appropriate experience in the management of infectious diseases.
The generic medicine Tigecycline Accord (tigecycline) also received a positive opinion for the treatment of complicated skin and soft tissue infections (excluding diabetic foot infections) and complicated intra-abdominal infections in adults and in children from the age of eight years, only in situations where alternative antibiotics are not suitable.