Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis

In continuation of my up date on isavuconazole

Isavuconazole (BAL4815) is an experimental triazole antifungal. Its prodrug, isavuconazonium sulfate (BAL8557) is currently in two Phase III clinical trials (SECURE and VITAL), the results of which are expected in the second half of 2013. 

Basilea Pharmaceutica Ltd. reports today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis/candidemia, a potentially life-threatening infection caused by Candida yeasts. Isavuconazole has previously been granted orphan drug status in the European Union and the U.S. for the treatment of invasive aspergillosis and mucormycosis.

Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis

Astellas Pharma to exclusively commercialize isavuconazole in the U.S. and Canada

Isavuconazole (BAL4815) is a triazole antifungal. Its prodrug, isavuconazonium sulfate (BAL8557) is currently in two Phase IIIclinical trials (SECURE and VITAL), the results of which are expected in the second half of 2013.

On May 28, 2013, Basilea Pharmaceutica, the maker of the drug, announced it had been granted orphan drug status by the U.S. Food and Drug Administration (FDA).

Now Astellas Pharma Inc. (Tokyo:4503, "Astellas") announced today that the company has amended the License, Co-Development and Co-Promotion Agreement on isavuconazole under co-development with Basilea Pharmaceutica Ltd. ("Basilea"). Based on this amendment, the territories subject to the License Agreement have been changed to reflect that Astellas will be responsible for all regulatory filings and will exclusively commercialize and assume full responsibility for manufacturing isavuconazole in the U.S. and Canada.

Astellas Pharma to exclusively commercialize isavuconazole in the U.S. and Canada

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

In continuation of my update on Isavuconazole

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis