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Astellas Launches CRESEMBA® (isavuconazonium sulfate) in the United States for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis

NORTHBROOK, Ill., April 27, 2015 /PRNewswire/ -- Astellas announced today that CRESEMBA® (isavuconazonium sulfate), the prodrug for isavuconazole, is now available 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.

Astellas is a pharmaceutical company dedicated to improving the health of people around the world.

On March 6, 2015, the U.S. 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 U.S. 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.

About Invasive Aspergillosis
Invasive aspergillosis is a life-threatening fungal infection that is seen predominantly in immunocompromised patients, such as patients with leukemia. Invasive aspergillosis is known for high morbidity and mortality.

About Invasive Mucormycosis
Invasive mucormycosis is a rapidly progressing and devastating invasive fungal infection. Invasive mucormycosis is also known for high morbidity and mortality.

About CRESEMBA®
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.

Important Safety Information for CRESEMBA® (isavuconazonium sulfate)
CRESEMBA is contraindicated in persons with known hypersensitivity to isavuconazole.

Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with CRESEMBA is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole.

Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John's wort, or long acting barbiturates with CRESEMBA is contraindicated because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole.

CRESEMBA shortened the QTc interval in a concentration-related manner. CRESEMBA is contraindicated in patients with familial short QT syndrome.

Hepatic Adverse Drug Reactions (e.g., elevations in ALT, AST, alkaline phosphatase, total bilirubin) have been reported in clinical trials and were generally reversible and did not require discontinuation of CRESEMBA. Cases of severe hepatic adverse drug reactions including hepatitis, cholestasis or hepatic failure including death have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with azole antifungal agents, including CRESEMBA. Evaluate liver tests at the start and during therapy. Monitor patients who develop liver abnormalities during CRESEMBA therapy for severe hepatic injury. Discontinue if clinical signs and symptoms consistent with liver disease develop that may be attributable to CRESEMBA.

Infusion-related reactions including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia were reported during intravenous administration of CRESEMBA. Discontinue the infusion of CRESEMBA if these reactions occur.

Serious hypersensitivity and severe skin reactions, such as anaphylaxis or Stevens Johnson syndrome, have been reported during treatment with other azole antifungal agents. Discontinue CRESEMBA if a patient develops a severe cutaneous adverse reaction. Caution should be used when prescribing CRESEMBA to patients with hypersensitivity to other azoles.

During pregnancy, CRESEMBA may cause fetal harm when administered, and should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the fetus. Women who become pregnant while receiving CRESEMBA are encouraged to contact their physician.

Following dilution, CRESEMBA intravenous formulation may form precipitate from the insoluble isavuconazole. Administer CRESEMBA through an in-line filter.

The most frequent adverse events among CRESEMBA-treated patients were: nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (16%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%).

The adverse reactions which most often led to permanent discontinuation of CRESEMBA therapy during the clinical trials were: confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea (0.5%), epilepsy (0.5%), respiratory failure (0.5%), and vomiting (0.5%).

For Full Prescribing Information, please visit here.

About Astellas Infectious Disease
Astellas is committed to the field of infectious diseases. Astellas is expanding the knowledge base of this therapeutic area and empowering physicians to make evidence-based clinical decisions.

Astellas' proud history of collaborating with investigators around the world provides ideal environments to study compounds that have the potential for significant breakthroughs for patients. In fact, Astellas has performed some of the world's largest clinical trials in fungal infections.

About Astellas
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. For more information on Astellas, please visit our website at www.astellas.us, follow us on Twitter at www.twitter.com/AstellasUS or like our Facebook page at www.facebook.com/AstellasUS.

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SOURCE Astellas

For further information: Marjorie Moeling, Marjorie.Moeling@astellas.com, 847-682-7471
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