Basilea Pharmaceutica Ltd. Logo
 

Isavuconazole

 
 

Isavuconazole Isavuconazole is an intravenous and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States (US) for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis.1 In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.2, 3

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

Basilea currently commercializes isavuconazole in Germany, Italy, the UK and Austria and is seeking national pricing and reimbursement in additional EU countries. In the US the drug is commercialized by Basilea's license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is currently not approved for commercial use.


References
1. CRESEMBA® US prescribing information
2. European Public Assessment Report (EPAR) CRESEMBA® 
3. The European marketing authorization for isavuconazole is valid in all 28 European Union (EU) member states as well as in Iceland, Liechtenstein and Norway.

 
Info
 
 
 

IDSA Infectious Diseases Society of America