FDA Approves Astellas’ Cresemba for Rare but Serious Fungal Infections

The US Food and Drug Administration (FDA) has approved Astellas’ new antifungal drug to treat two rare, often fatal invasive fungal infections.

The agency approved Astellas’ New Drug Application (NDA) for the use of Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis, also known as zygomycosis. These life-threatening fungal infections predominantly occur in immunocompromised patients.

“We’re pleased with the FDA’s approval of Cresemba for use in treating patients with these life-threatening infections,” said Bernie Zeiher, MD, executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. “We are proud to be able to offer a new treatment for patients in an area for which there is a significant unmet medical need.”

Cresemba is an oral and injected solution for patients with these fungal infections. These life-threatening infections are known for high morbidity and mortality. Astellas gained access to the drug in 2010, when it entered into a deal with Switzerland’s Basilea Pharmaceutica. Astellas paid $86 million upfront and promised roughly $550 million in milestone payments. With the FDA’s approval, Basilea is eligible to receive CHF 30 million.

Cresemba is now the sixth drug to receive FDA approval under the agency’s Qualified Infectious Disease Product (QIDP) program, which provides companies with an additional five years of market exclusivity on products that target life-threatening infections.

“It is extremely gratifying to have been a part of the clinical trials of Cresemba since inception, knowing patients and their physicians will now have this option,” said Thomas F. Patterson, MD, FACP, FIDSA, Division of Infectious Diseases chief at The University of Texas Health Science Center at San Antonio and director of the San Antonio Center for Medical Mycology. “Cresemba is an important new therapy for physicians treating patients with invasive aspergillosis and invasive mucormycosis fungal infections.”

Cresemba is also being evaluated for treatment of another serious fungal infection, known as invasive candidiasis.

Source: Astellas

Last updated: 3/9/15; 1:40pm EST

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