(Reuters) - U.S. health regulators on Friday approved Japanese drugmaker Astellas Pharma Inc’s drug for the treatment of two rare, often fatal invasive fungal infections that target patients with blood cancers.
The Food and Drug Administration approved sale of the anti-fungal drug, Cresemba, for use against invasive aspergillosis and invasive mucormycosis.
The approval had been expected after an expert advisory panel to the FDA in January voted 11-0 that Astellas had demonstrated sufficient safety and efficacy to support Cresemba for aspergillosis and 8-2 for mucormycosis. The panel cited the need for additional treatments.
In clinical trials, the drug, also known as isavuconazonium, proved at least as safe and effective in reducing mortality as voriconazole, which Pfizer sells under the brand name Vfend, the current standard of care for aspergillosis.
“Today’s approval provides a new treatment option for patients with serious fungal infections and underscores the importance of having available safe and effective antifungal drugs,” Edward Cox, head of evaluation of antimicrobial products for the FDA, said in a statement.
Cresemba received a Qualified Infectious Disease Product (QIDP) designation from the agency, which is used as an incentive to spur development of antibacterial or antifungal drugs that treat serious or life-threatening infections. The designation comes with an additional five years of marketing exclusivity.
Astellas expects to begin selling the drug “in the coming months,” said Jim Robinson, head of the company’s U.S. operations.
Invasive aspergillosis is a rare, life-threatening fungal infection seen predominantly in patients with compromised immune systems, such as those with leukemia. Mucormycosis is a very rare, rapidly progressing invasive fungal infection also with high rates of morbidity and mortality.
Cresemba is also being tested against another serious fugal infection called invasive candidiasis, Robinson said. That would address a larger patient population than the two infections in the initial approval.
Reporting by Bill Berkrot; Editing by Diane Craft, Bernard Orr
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