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Isavuconazole

 
 

Isavuconazole Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It received marketing authorization in Europe for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.1 It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 In Switzerland, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of mucormycosis in adult patients who are resistant to or intolerant of amphotericin B and in adult patients with moderate to severe renal impairment.3

Isavuconazole has orphan drug designation for the approved indications in Europe and the U.S. and was designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) under the Generating Antibiotics Incentives Now (GAIN) Act.

Basilea has entered into license and distribution agreements for isavuconazole in the U.S., Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel. In Europe, it is currently marketed in Germany, Italy, the United Kingdom, France, Spain, Austria and the Nordic countries.


References
1. European Public Assessment Report (EPAR) Cresemba

2. Cresemba U.S. prescribing information

3. Full indication in: Swissmedic-approved information for healthcare professionals as of August 2017

 
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IDSA Infectious Diseases Society of America