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CRESEMBA (isavuconazole), antifungal
INFECTIOUS DISEASE - New medicinal product
Opinions on drugs -
Posted on
May 25 2016
Reason for request
Inclusion
No clinical added benefit demonstrated by comparison with other reference antifungals in the management of invasive aspergillosis and mucormycosis
- CRESEMBA is a new azole antifungal available in oral and intravenous forms, with Marketing Authorisation in the treatment of invasive aspergillosis and mucormycosis in patients for whom treatment with amphotericin B is inappropriate.
- It has not demonstrated a clinical added benefit compared with voriconazole (VFEND) in terms of efficacy in the treatment of invasive aspergillosis.
- Limited data are available in the treatment of mucormycosis
- Like other azole antifungals, its safety profile is marked by disturbances of liver function and skin disorders.
- It is a first-line therapeutic option in the treatment of invasive aspergillosis and second-line in the treatment of mucormycosis, especially in patients with renal failure.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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