Emblaveo (aztreonam-avibactam): new antibiotic to fight infections caused by multidrug-resistant bacteria reccomended by the CHMP for approval
The CHMP 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.
The full indication is:
Emblaveo is indicated for the treatment of the following infections in adult patients (see sections 4.4 and 5.1):
- Complicated intra-abdominal infection (cIAI)
- Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
- Complicated urinary tract infection (cUTI), including pyelonephritis
Emblaveo is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4, and 5.1).
Emblaveo is a fixed-dose combination of two active substances, aztreonam and avibactam. Aztreonam is already authorised for use in the EU on its own and avibactam is authorised for use in combination with another antibiotic (ceftazidime). Aztreonam is an antibiotic that belongs to the group ‘beta-lactams’. It works by attaching to proteins on the surface of the bacteria. This prevents the bacteria from building their cell walls, which kills them.
Avibactam blocks the action of many of the bacterial enzymes called beta-lactamases. These enzymes enable bacteria to break down beta-lactam antibiotics, such as aztreonam, making them resistant to the antibiotic’s action. By blocking these enzymes, avibactam restores the activity of aztreonam against aztreonam-resistant bacteria.
Emblaveo will be available to be given by infusion into a vein.
EMA’s human medicines committee (CHMP) considered that the benefits of Emblaveo outweigh its risks for patients with infections caused by Gram-negative bacteria when they have few or no therapeutic options to fight the disease. Aztreonam has been shown to be effective at treating a range of serious infections. Microbiology data indicate that aztreonam in combination with avibactam will be effective in infections caused by many multidrug-resistant aerobic Gram-negative pathogens and the combination could therefore address an unmet medical need.
Emblaveo was evaluated under EMA's accelerated assessment mechanism because it is considered to be of major public health interest.
EMA’s recommendation is based on the safety and efficacy data already available for each active substance and the results of two phase III randomised studies submitted by the applicant. The studies were not designed to demonstrate efficacy but do provide safety and complementary data for the combination. This is in line with EMA's guideline that allows for a flexible approach in the development of new antibiotics for human use targeting multidrug-resistant pathogens for which new treatments are needed.
The most frequent side effects in patients treated with Emblaveo 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.