dm+d

38994811000001100

Refrigerated Storage

FetcrojaShionogi

Shionogi
Fetcroja
Powder for concentrate for solution for infusion

In the event of an inadvertent temperature excursion the following data may be used:
The product is stable when exposed to a temperature excursion between -20°C to 30°C for less than 6 hours.
The product can be returned to the fridge and no change in expiry date is required if exposed to the above conditions.
Contact Shionogi in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

3 March 2022
London MI Service

New Medicines

FetcrojaSevere gram negative infection in patients with limited options

Information

Fetcroja
New molecular entity
Shionogi
Shionogi

Development and Regulatory status

Launched
Launched
Approved (Licensed)
September 2020
Sep 20Launched in the UK [15]
Apr 20Approved in EU [14].
Feb 20Recommended for EU approval by CHMP - the full indication is "for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.” It is proposed that the medicine be prescribed only after consultation with a physician with appropriate experience in the management of infectious diseases [13].
Nov 19Approved in US for the treatment of complicated urinary tract infections (cUTI) in patients who have limited or no alternative treatment options. [11]
Apr 19Filed in EU [8].
Jan 19Company pipeline does not indicate when EMA and FDA filings for approval will be submitted [7].
Dec 18Filed in US [9].
Sep 18Shionogi plans to file in the US in 2017 and in the EMA in 2018 [5].
Jul 17PIII NCT02714595 primary data collection Dec 17, completion May 18 [3].
Mar 17Shionogi plans to file an NDA for cefiderocol, in 2017 [1].

Category

Novel siderophore cephalosporin antibiotic
The eligible population is difficult to estimate and may vary according to local resistance patterns. In 2017/18 there were ~180,000 admissions for complicated urinary tract infections (cUTI’s), sepsis and pneumonia due to gram-negative bacteria in England. About 10% of bacteria are resistant to currently available antibiotics so ~18,000 people could require antibiotics reserved for resistant infections. [12]
Severe gram negative infection in patients with limited options
Intravenous

Trial or other data

Dec 20The 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 Fetcroja will be made available to patients via a subscription-based payment model from early 2022 [18].
Dec 20Fetcroja 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. This pilot is intended to encourage drug developers to resume and increase research and development into new antibiotic medications, given that this area is lacking in innovation due to the economic challenges associated with it. This is due in large part to the fact that the newest antibiotic drugs are reserved as last-line treatments, and are often only used when all other treatment options have been exhausted [17].
Oct 20PIII CREDIBLE-CR study (n=152) reports cefiderocol had similar clinical and microbiological efficacy to best available therapy (pre-specified before randomisation and maximum of three drugs) in this population [16].
Jan 19PIII CREDIBLE-CR study (NCT02714595) still recruiting with a primary completion date of May 19 [6].
Mar 18Study NCT02714595 still recruiting with a primary completion date of Sept 18 [4].
Mar 17NCT02714595 - primary data due Dec 17
Mar 16PIII trial initiated in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens (CREDIBLE-CR; NCT02714595; 1424R2131). The randomised, open-label trial has initiated recruitment of approximately 150 patients in the US, and will expand to Croatia, Germany, Israel, Italy, Japan, South Korea and Taiwan [1].

Evidence based evaluations