Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
The committee recommended granting a marketing authorisation for 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.
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.
The CHMP also gave a positive opinion to Niapelf (paliperidone), a generic medicine for the treatment of schizophrenia…
