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European Commission approves marketing authorization for cefiderocol

European Commission approves marketing authorization for cefiderocol
European Commission approves marketing authorization for cefiderocol
  • The European Commission (EC) has approved an antibiotic drug cefiderocol which was developed by Japanese drug maker Shionogi.
  • It is the first treatment which offers coverage against all Gram-negative pathogens defined as a critical priority by the World Health Organization (WHO).
  • The marketing authorization was based on clinical efficiency data from three key studies.

Shionogi & Co. Ltd., the Japanese pharmaceutical company, has reportedly received EC (European Commission) marketing authorization for cefiderocol, a new antibiotic developed for treating infections caused due to aerobic Gram-negative bacteria in adults with restricted treatment options.

Reportedly, the EC authorization of cefiderocol was based on the non-clinical data package comprising the PK/PD data package. Data from several multinational surveillance studies indicate that Cefiderocol has extensive in vitro activity against a comprehensive spectrum of aerobic Gram-negative pathogens.

These consist of all three critical pathogens defined by the WHO (World Health Organization); Pseudomonas aeruginosa, carbapenem-resistant Acinetobacter baumannii, Enterobacterales, and Stenotrophomonas maltophilia. The drug also showed in vitro activity against bacteria that contain extremely problematic resistant enzymes like ESBLs, AmpC, metallo-carbapenemases, and serine-.

As per the sources, data from three clinical studies including CREDIBLE-CR, APEKS-NP, and APEKS-cUTI has supported the marketing authorization of the drug. Data from the studies showed the efficacy of cefiderocol in patients with cUTI (complicated urinary tract infections), HAP (hospital-acquired pneumonia), VAP (ventilator-associated pneumonia), sepsis (including cIAI (complicated intraabdominal infection) and SSSI (skin and skin structure infection) and bacteraemia.

One of the clinical studies involved patients with Gramnegative infections caused due to multidrug-resistant pathogens including carbapenem-resistant bacteria from the WHO priority list.

Prof. Peter Hawkey, Institute of Microbiology and Infection, University of Birmingham said Cefiderocol treatment is useful against all the critical pathogens defined by World Health Organization and would be a much-required option for the treatment of severe Gram-negative infections.

Source Credit - https://www.afp.com/en/news/1313/shionogi-receives-european-commission-marketing-authorisation-fetcrojar-cefiderocol-treatment-infections-due-aerobic-gram-negative-bacteria-adults-limited-treatment-options-202004270057191

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Bhushan Tambe

A qualified computer graduate, Bhushan Tambe always nurtured a passion for words. Post his education, he decided to transform his penchant of penning down poetry and stories into a full-time career. Presently, Bhushan writes numerous articles for cuereport.com and a few other websites, on subjects spanning business, finance, and the like.