Isavuconazole(drug substance:isavuconazonium sulfate)艾沙康唑注射液，艾沙康唑胶囊
新型抗菌药isavuconazole静脉注射及口服药获得FDA批准，Isavuconazole是一种水溶性的广谱真菌抑制剂,临床研究表明其对多种严重的真菌感染具有优异的疗效。

Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of invasive fungal infections. This kind of infections predominantly occurs in immunocompromised patients such as cancer patients undergoing chemotherapy.
A European Union (EU) Marketing Authorization Application and a U.S. New Drug Application for isavuconazole are currently under regulatory review by the European Medicines Agency (EMA) and the U.S. FDA, respectively, for the treatment of invasive aspergillosis and mucormycosis (also known as zygomycosis) in adults.
Isavuconazole was designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) under the U.S. Generating Antibiotics Incentives Now (GAIN) Act for the treatment of invasive aspergillosis, mucormycosis, and candidiasis. In addition, it has EU and U.S. orphan drug status for invasive aspergillosis and mucormycosis.
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 exclusive license holder.
About the isavuconazole phase 3 program
The phase 3 program with isavuconazole includes three studies, SECURE, VITAL and ACTIVE. The SECURE study was a global double-blind randomized study and eva luated the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole in the primary treatment of invasive fungal disease caused by Aspergillus species or other filamentous fungi. The VITAL study was an open-label study of isavuconazole in the treatment of aspergillosis patients with pre-existing renal impairment or patients with invasive fungal disease caused by emerging and often fatal molds such as Mucorales, yeasts, or dimorphic fungi. The ACTIVE study eva luates the safety and efficacy of intravenously (i.v.) and orally administered isavuconazole versus i.v. caspofungin followed by oral voriconazole in the treatment of candidemia and other invasive infections caused by Candida yeasts.1 Results from the SECURE2 and VITAL3 studies have already been reported, while enrollment into the ACTIVE study is anticipated to be completed by early 2015.
The need for new antifungal therapies
The expansion of the immunocompromised patient population including cancer patients with chemotherapy-induced neutropenia and transplant recipients receiving immunosuppressive therapy has led to an increased incidence of invasive fungal infections.
Invasive aspergillosis is estimated to occur in 5-13% of bone marrow transplant recipients, 5-25% of patients who have received heart or lung transplants, and 10-20% of patients who have received intensive chemotherapy for leukemia.4 Mortality rates for transplant patients with invasive aspergillosis have been reported to be between 34% and 58%.5 Around 47% of solid organ transplant recipients who developed invasive aspergillosis had renal insufficiency and acute renal failure was reported for 43% of intensive care unit (ICU) patients with invasive aspergillosis, compared to 20% in the general ICU population.5, 6
Mucormycosis (also known as zygomycosis) is an often lethal fungal infection caused by certain emerging molds. Mucormycosis is associated with high morbidity and mortality rates in immunocompromised patients such as patients undergoing chemotherapy or bone marrow transplantation.7, 8 Left untreated, mucormycosis is almost always lethal, and even with appropriate medical management, mortality rates remain high.9
There is a high medical need to address the limitations of current therapies, most importantly the gaps in the antifungal spectrum, unwanted side effects, limited dosing flexibility as well as the development of resistance.