Mixed bag of recommendations from EMA/CHMP January meeting

26 January 2024

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its January 2024 meeting, but rejected two others.

The committee recommended granting a marketing authorization for UK drugmaker Advanz Pharma’s Exblifep (cefepime/enmetazobactam), for the treatment of complicated urinary tract infections, including pyelonephritis, hospital-acquired pneumonia, including ventilator associated pneumonia, and for the treatment of patients with bacteraemia (the presence of bacteria in the bloodstream) caused by the infections listed above.

China-based Evive Biotechnology’s Ryzneuta (efbemalenograstim alfa) received a positive opinion from the CHMP for the reduction in the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the incidence of febrile neutropenia due to chemotherapy.

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