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Positive CHMP recommendation for antibiotic combination

EMA has recommended granting a marketing authorisation for Emblaveo for treatment of infections caused by multidrug-resistant bacteria.

Positive CHMP recommendation for antibiotic combinationPositive CHMP recommendation for antibiotic combination

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria.

“Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mortality,” said James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine, Anti-Infectives and Hospital, Pfizer.

“If approved, Emblaveo® could offer hope to adult patients with life-threatening Gram-negative bacterial infections that currently have limited treatment options.”

Emblaveo is a fixed-dose combination of two active substances, aztreonam and avibactam. It will be available to be given by infusion into a vein.

The novel antibiotic combination was evaluated under EMA’s accelerated assessment mechanism as it is considered of “major public health interest.”

Data supporting the positive recommendation of Emblaveo 

EMA’s positive recommendation for Emblaveo was based on the safety and efficacy data already available for each active substance and the results of two separate Phase III randomised studies REVISIT (NCT03329092) and ASSEMBLE (NCT03580044).

Aztreonam is already authorised for use in the EU. Avibactam is authorised for use in combination with another antibiotic (ceftazidime). 

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. The most common side effects in patients treated with Emblaveo were a decrease in the number of red blood cells, elevated levels of liver transaminase and diarrhoea.

Emblaveo was jointly developed with AbbVie. Pfizer holds the global rights to commercialise this investigative therapy outside of the US and Canada, where the rights are held by AbbVie.

Pfizer said the European Commission will review the CHMP recommendation and is expected to make a final decision in the “coming months.”  If granted, the MAA would be valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway.

Marketing authorisation applications for Emblaveo are planned for submission in other countries, Pfizer added.