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fidaxomicin (Dificlir)

Advice

following a full submission:

fidaxomicin (Dificlir®) is accepted for restricted use within NHS Scotland.

Indication under review:  treatment of adults with Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).

SMC restriction: Treatment of adults with a first CDI recurrence on the advice of local microbiologists or specialists in infectious diseases.

Fidaxomicin demonstrated non-inferiority to another antibiotic in the clinical cure of Clostridium difficile infection and superiority in reducing recurrence.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC for first-line use in adults with severe CDI.

Drug Details

Drug Name: fidaxomicin (Dificlir)
SMC Drug ID: 791/12
Manufacturer: Astellas Pharma Ltd
Indication: Treatment of clostridim difficile infections (CDI) also known as C. Difficile-associated diarrhoea (CDAD)
BNF Category:
Sub Category: 5.1 Antibacterial drugs
Submission Type: Full submission
Status: Restricted
Date Advice Published: 9 July 2012

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