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New antibiotic combination for multidrug-resistant infections receives positive CHMP opinion

The antibiotic aztreonam-avibactam (brand name Emblaveo) has received a positive opinion to treat multidrug-resistant infections from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), its manufacturer Pfizer has announced.

Aztreonam-avibactam is recommended for use in the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.

The antibiotic combination, which is administered via an infusion into a vein, will also be indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

Aztreonam, a monobactam β-lactam, is already authorised for use in the EU on its own (brand name Cayston) and avibactam, a recent broad-spectrum β-lactamase inhibitor, is authorised for use in combination with the antibiotic ceftazidime (brand name Zavicefta).

The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that co-produce metallo-β-lactamases (MBLs) and other β-lactamases.

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If approved, this new fixed-dose combination would be the first β-lactam/β-lactamase inhibitor combination for treating serious bacterial infections caused by multidrug-resistant Gram-negative bacteria, including MBL-producing bacteria, approved for use in the EU.

The drug combination was evaluated under EMA’s accelerated assessment mechanism due to it being considered of major public health interest.

Safety and efficacy of aztreonam-avibactam

The positive CHMP opinion is based on the safety and efficacy data already available for each active substance and the results of two phase 3 randomised studies REVISIT and ASSEMBLE.

While the studies were not designed to demonstrate efficacy, they do provide safety and complementary data for the combination suggesting it is a well-tolerated and effective treatment option against multidrug-resistant Gram-negative bacteria, the EMA said.

The most frequent side effects in patients treated with aztreonam-avibactam were a decrease in the number of red blood cells, elevated levels of liver transaminase and diarrhoea. This is in line with the documented safety information available for each individual substance.

Earlier in 2024, the new antibiotic combination cefepime-enmetazobactam (brand name Exblifep) received a positive CHMP opinion for the treatment of certain adult patients with complicated urinary tract infections.