Astellas, a pharmaceutical company dedicated to improving the health of people around the world, has launched Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, in the United States for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). These are life-threatening fungal infections predominantly occurring in immunocompromised patients.
On March 6, 2015, the US Food and Drug Administration (FDA) approved a New Drug Application (NDA) for the use of Cresemba for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.
"The launch of Cresemba in the US marks the availability of an important new treatment option for patients and healthcare professionals fighting these life-threatening fungal infections," said Bernie Zeiher, M.D., divisional president and head of Global Development at Astellas. "Given the high morbidity and mortality rates associated with invasive aspergillosis and invasive mucormycosis, we are excited to provide physicians and patients with this alternative therapy in an area of significant unmet medical need."
"We are proud to add a new azole antifungal to our existing infectious disease portfolio with the launch of Cresemba," said Jim Robinson, president of Astellas Pharma US. "This launch builds upon our strong heritage of bringing innovation and renewed hope to patients in need, including those affected by these devastating fungal infections."
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 invasive mucormycosis in adults.
Invasive aspergillosis is a life-threatening fungal infection that is seen predominantly in immunocompromised patients, such as patients with leukaemia. Invasive aspergillosis is known for high morbidity and mortality.
Invasive mucormycosis is a rapidly progressing and devastating invasive fungal infection. Invasive mucormycosis is also known for high morbidity and mortality.
Cresemba (isavuconazonium sulfate) is the prodrug containing the active antifungal agent isavuconazole, an azole antifungal indicated for use in the treatment of invasive aspergillosis and invasive mucormycosis.