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34180511000001105

New Medicines

Zavicefta (EU), Avycaz (US) Pneumonia, intra-abdominal infections and urinary tract infections in adolescents and children

Information

Zavicefta (EU), Avycaz (US)
Licence extension / variation
Pfizer
Not Known

Development and Regulatory status

Launched
Launched
None
November 2020
Nov 20Approved in the EU [4].
Sep 20EU positive opinion to extend the licence from use only in adults to include treatment of adolescents and children (and to make some other changes to wording of the indication). The proposed new indication is use in adults and children aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI); Complicated urinary tract infection (cUTI), including pyelonephritis; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and children aged 3 months and older with limited treatment options (previously only adults) [2].

Category

Cephalosporin and a beta-lactamase inhibitor
HAP occurs mostly in patients who are severely debilitated, immunocompromised or mechanically ventilated. Infection occurring less than five days after hospital admission is usually caused by S. pneumoniae. Infection occurring after this time is usually caused by H. influenzae , methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and other non-pseudomonal Gram-negative bacteria [1].
Pneumonia, intra-abdominal infections and urinary tract infections in adolescents and children
Bladder instillation

Trial or other data

Dec 20Zavicefta has been selected for inclusion in a pilot subscription reimbursement scheme, launched by NICE and NHSE&I. The scheme will pilot a model that reimburses pharma companies for antimicrobials based on a health technology value assessment of their value to the NHS, as opposed to the volumes of the drug used. The evaluation process for the pilot subscription reimbursement scheme will be undertaken by NICE over the next 12 months. The output of these evaluations will inform the subscription payment price the company will receive for its product. It is anticipated that Zavicefta will be made available to patients via a subscription-based payment model from early 2022 [5].

Evidence based evaluations