Basilea Pharmaceutica Ltd. reported this week that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the oral and intravenous treatment of invasive candidiasis, a life-threatening invasive fungal infection caused by Candida yeasts.
A QIDP designation, granted under the U.S. GAIN Act, provides priority review and a five-year extension of market exclusivity, should the product be approved in the United States. Isavuconazole was previously granted QIDP designation for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are severe mold infections. In addition, isavuconazole has FDA fast-track status and received U.S. and European Union orphan drug designations for invasive aspergillosis and mucormycosis.
Prof. Achim Kaufhold, Basilea’s Chief Medical Officer, commented: “Invasive candidiasis is a nosocomial infection associated with high mortality, frequently occurring in critically ill patients, such as cancer patients undergoing chemotherapy, organ transplantation, and invasive surgical procedures. Moreover, the incidence of Candida infections has been increasing over past decades.” He added: “We are very pleased that the FDA has granted this third QIDP designation to isavuconazole. QIDP designations are granted to antibacterial or antifungal drugs which are intended to treat serious or life-threatening infections caused by certain qualified pathogens, including Candida species, that have the potential to pose a serious threat to public health.”
In addition, the company announced this week they submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis).
Ronald Scott, Basilea’s Chief Executive Officer, stated: “New antifungal therapies are urgently needed due to the increasing number of immunocompromised patients who are at risk for developing invasive fungal infections such as cancer patients undergoing chemotherapy. The isavuconazole regulatory submission in the EU is a major achievement for Basilea and complements the U.S. submission by our partner Astellas.”
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of life-threatening invasive fungal infections which predominantly occur in immunocompromised patients.
Isavuconazole is being co-developed with Astellas Pharma Inc. Basilea holds full rights to isavuconazole in markets outside of the U.S. and Canada where Astellas is the license holder.