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Choosing between oral fidaxomicin options

20 October 2021Local decision makers should choose between the options for giving fidaxomicin orally. Licensing status and other factors affect decision making.
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New Medicines

Dificlir (EU), Dificid (US)Clostridium difficile infection in children - granules for oral suspension (also tablets)

Information

Dificlir (EU), Dificid (US)
New formulation and licence extension / variation
Astellas
Optimer

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Approved (Licensed)
Feb 20Approved in EU [15].
Jan 20Approved in US [14].
Dec 19Recommended for EU approval by CHMP - the amended indication for the tablets is "for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg (see section 4.2 and 5.1)." Additionally, CHMP also gave a positive opinion on a new formulation, granules for oral suspension (40 mg/ml), indicated for: “the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age (see section 4.2 and 5.1)." For both formulations, the recommendation is that "Consideration should be given to official guidelines on the appropriate use of antibacterial agents”[12].
Jan 19Filed in EU [12].
Jan 19PIII trials complete. [9]
Mar 18Still in PIII trials in this population.[7,8]
Oct 16Remains PIII [5].
Oct 15PIII development continues in EU [3].
Aug 14PIII in EU [1].

Category

DNA-directed RNA polymerase inhibitor, narrow spectrum antibacterial agent
A total of 13,286 cases of C.difficile infection were reported by hospitals in 2017-18, an increase of 3.4% from 2016/17 and a decrease of 76.1% from 2007/08. Rates are greatest in the elderly but an increase among younger age groups was noted.[11] A review article estimated that, in the USA from 2001-2006, hospital admissions in children due to CDI increased from 2.4 to 4.0 per 1000 and the number of hospital-acquired cases of CDI in children increased from 4.4 to 6.5 per 10000 patient-days. [10]
Clostridium difficile infection in children - granules for oral suspension (also tablets)
Oral

Trial or other data

Jan 19Results from PIII SUNSHINE study (NCT02218372) showed that the percentage of pts With Confirmed Clinical Response (CCR) at end of treatment (EOT) +2 Days [primary outcome measure] was 77.6% in the fidaxomicin gp vs. 70.5% in the vancomycin gp (difference 7.5%, 95% CI; -7.4 to 23.9). The rate of serious ADR´s was slightly higher in the vancomycin gp (27% vs. 24% in the fidaxomicin gp). The overall rate of ADR´s was higher with vancomicin; 48% vs. 37% and the most common ADR´s (>5% frequency) with fidaxomicin were abdominal pain, constipation, diarrhoea, vomiting, pyrexia and headache.[9]
Mar 18PIII SUNSHINE study (NCT02218372) still recruiting. The estimated primary completion date is listed as February 2018.[7]
Dec 16NCT02218372 estimated completion date now June 2017 [6].
Jan 16NCT02218372 is still recruiting patients and date study due to complete is now Feb 17 [4].
Nov 14A PIII study (NCT02218372) to investigate the safety and efficacy of fidaxomicin (oral suspension or tablets) and vancomycin (oral liquid or capsules) in 144 pediatric subjects with (CDAD) (SUNSHINE) is to begin recruitment in the EU. The study is expected to complete in Feb 2016 [2].

Evidence based evaluations