Astellas Pharma, Inc.
) announced positive top-line data from a phase III study
(SECURE) on its invasive aspergillosis candidate, isavuconazole.
Isavuconazole is an azole antifungal agent, jointly developed by
Basilea Pharmaceuticals AG and Astellas. The companies had
entered into an agreement in Feb 2010.
The global, double-blind, randomized phase III study evaluated
the safety and efficacy of once-daily isavuconazole versus
) Vfend (twice daily). The study achieved its primary objective
of non-inferiority to Vfend for the treatment of invasive fungal
disease caused by the Aspergillusspecies. The all-cause-mortality
was 18.6% in the isavuconazole arm and 20.2% in the Vfend
The secondary endpoint of overall success rate at the
end-of-therapy in patients with proven/probable disease was
almost similar between the two groups.
As per information provided by Astellas, invasive
aspergillosis is found in 5-13% of bone marrow transplant
patients, 5-25% of heart or lung transplant patients and 10-20%
of recipients of intensive chemotherapy patients for
Besides the SECURE study, the candidate is currently being
evaluated in two other phase III studies, namely, VITAL and
The open-label phase III VITAL study evaluates isavuconazole
for the treatment of patients with invasive life-threatening
fungal disease and the treatment of aspergillosis patients with
pre-existing renal impairment. Enrolment is complete and the
review of diagnosis and outcomes by the Independent Data Review
Committee is in progress.
The double-blind, randomized phase III ACTIVE study evaluates
the use of isavuconazole (intravenous and oral) versus
Merck & Co, Inc.
) Cancidas (intravenous) followed by Vfend (oral) for the
treatment of candidemia and other invasive candida infections.
The enrollment in the ACTIVE study is in progress.
The U.S. Food and Drug Administration (FDA) has granted fast
track and orphan drug designation to isavuconazole.
) is also developing an antifungal agent, albaconazole. The
candidate is being developed for the treatment of vulvo-vaginal
candidiasis, onychomycosis and other antifungal indications.
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