AsianScientist (Mar. 13, 2015) – The US Food and Drug Administration (FDA) has approved Japanese pharmaceutical Astellas’ New Drug Application for the use of CRESEMBA® (isavuconazonium sulfate), the prodrug for isavuconazole. CRESEMBA® is used in the treatment of invasive aspergillosis and invasive mucormycosis, life-threatening fungal infections predominantly occurring in immunocompromised patients.
“We’re pleased with the FDA’s approval of CRESEMBA for use in treating patients with these life-threatening infections,” said Dr. Bernie Zeiher, executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. “We are proud to be able to offer a new treatment for patients in an area for which there is a significant unmet medical need.”
The safety and efficacy profile of CRESEMBA in patients with invasive aspergillosis was demonstrated based on data from two Phase 3 clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of adult patients with invasive aspergillosis; and VITAL, an open-label non-comparative study of CRESEMBA in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi.
The recommended loading dose of CRESEMBA is one reconstituted vial or two capsules (372 mg isavuconazonium sulfate equivalent to 200 mg of isavuconazole) every eight hours for six doses (48 hours) via oral or intravenous administration. The recommended maintenance dose is one reconstituted vial or two capsules (372 mg isavuconazonium sulfate equivalent to 200 mg of isavuconazole) once per day via oral or intravenous administration, starting 12 to 24 hours after the last loading dose.
The CRESEMBA New Drug Application (NDA) was submitted by Astellas on July 8, 2014. CRESEMBA is being co-developed with Basilea Pharmaceutica International Ltd. Basilea submitted a European Marketing Authorization Application on July 16, 2014 for the treatment of invasive aspergillosis and mucormycosis in adults.
Upon this approval, Astellas will pay a CHF 30 million milestone payment to Basilea Pharmaceutica International Ltd. under their license and co-development agreement.
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Source: Astellas.
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