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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.1

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, Japan, Latin America, the Middle East and North Africa (MENA) region, Canada, Russia, Turkey and Israel. In Europe, it is currently marketed in Germany, Italy, the United Kingdom, France, Austria and the Nordic countries. Pfizer is anticipated to assume the responsibility for commercializing the drug in Europe (excluding the Nordic countries) by the end of 2017. Basilea's license partner Astellas Pharma US markets the drug in the U.S. Outside the U.S. and the EU, isavuconazole is currently not approved for commercial use.


References
1. Cresemba U.S. prescribing information

 
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IDSA Infectious Diseases Society of America