Astellas', Basilea's Isavuconazole Granted FDA Orphan Drug Status For Invasive Candidiasis
By Cyndi Root
Astellas’ and Basilea’s Isavuconazole continues its upwards trajectory as the Food and Drug Administration (FDA) has granted the agent Orphan Drug status for invasive candidiasis. Astellas announced the designation in a press release, stating that the once-daily intravenous and oral broad-spectrum antifungal is being investigated for several types of fungal infections. Isavuconazole has previously been granted Orphan status for invasive aspergillosis and invasive mucormycosis, as well as Qualified Infectious Disease Product (QIDP) status for invasive candidiasis, invasive aspergillosis, and invasive mucormycosis. Astellas has submitted a New Drug Application (NDA) for invasive aspergillosis and invasive mucormycosis and expects the FDA to take action on that submission by March 8, 2015.
Bernie Zeiher, M.D., EVP of Global Development at Astellas, stated that the FDA’s decision to award Orphan status is evidence of the urgent need for more treatments for invasive candidiasis. He said, "Invasive candidiasis is a serious hospital-acquired fungal infection that is associated with increased morbidity and mortality in certain immunocompromised patients. Increasing reports of Candida resistance to available therapies necessitates the development of new antifungals to treat these serious infections.”
Isavuconazole
Isavuconazole, from the prodrug isavuconazonium sulfate, shows activity against yeasts and molds, including fatal molds like mucormycosis. Ongoing Phase 3 trials are investigating the agent against several targets. SECURE is evaluating isavuconazole vs. voriconazole. ACTIVE is studying isavuconazole vs. caspofungin, followed by oral voriconazole. Recently, Astellas reported at IDWeek in Philadelphia, PA that the VITAL trial found the drug was effective in treating invasive mucormycosis, eliciting a 31.4 percent overall response rate.
About Basilea
Basilea Pharmaceutica entered into a co-development and co-promotion agreement with Astellas in 2010 and amended the agreement in February 2014. The amended agreement calls for Astellas to continue developing and funding the candidemia phase 3 study, pursue regulatory approvals for invasive aspergillosis and invasive mucormycosis in the U.S. and Canada, and support Basilea’s applications in Europe. The financial arrangements continue as before with Basilea receiving milestone and royalty payments. The two companies intend to coordinate development and manufacturing activities while each is responsible for marketing in their own territories. Astellas and Basilea are working on plans to develop and commercialize isavuconazole in areas outside of the Europe, Asia, the U.S., and Canada.