12 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
The CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec) for the treatment of diabetes mellitus in adults.
The committee adopted a positive opinion for Emblaveo (aztreonam-avibactam), an antibiotic indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) that are resistant to many currently available antibiotics and where patients have limited or sometimes no treatment options. Emblaveo was evaluated under EMA’s accelerated assessment mechanism because it is considered to address an unmet medical need. See more details in the news announcement in the grid below…
