Positive CHMP opinion for Shionogi’s treatment of infections due to aerobic Gram-negative bacteria

Image of a form with ticks on it to show Shionogi receives positive CHMP opinion for FETCROJA® for treatment of infections due to aerobic Gram-negative bacteria

Shionogi has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the approval of FETCROJA® (cefiderocol), a new antibiotic for the treatment of infections due to aerobic Gram-negative bacteria in adult patients (18 years or older) with limited treatment options. 

The positive CHMP opinion of cefiderocol was based on the nonclinical data package, including the PK/PD data package, and data from three clinical studies in complicated UTI, nosocomial pneumonia and critically ill patients with confirmed carbapenem-resistant infection.

“We are delighted with the positive CHMP opinion which marks an important milestone in the journey to approval for this innovative new antibiotic,” said Takuko Sawada, Director of the Board, Executive Vice President.

“Cefiderocol has a unique mechanism of cell entry, exploiting the bacteria’s own iron uptake transporters to effectively enter the bacterial cell. This allows it to overcome the three major mechanisms of carbapenem-resistance in Gram-negative bacteria. If approved, cefiderocol will be an important new treatment option for patients with these particularly difficult to treat Gram-negative infections who have limited options available to them.”

Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed. In Europe about 25,000 patients die from an infection with selected multi-drug resistant bacteria every year. Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with higher mortality compared to those involving other strains.

If no action is taken, antibiotic resistance is predicted to kill 10 million people every year by 2050 at a cumulative cost to global economic output of 100 trillion USD. If approved, cefiderocol will be the first antibiotic to address all three major mechanisms of carbapenem-resistance and will be an important new treatment option to address this urgent unmet need.

The European Commission will review the CHMP opinion for treatment of infections due to aerobic Gram-negative bacteria and is expected to deliver its final decision later this year.