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FDA approves Cresemba for antifungal therapy
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The FDA has approved Cresemba to treat adults with invasive aspergillosis and invasive mucormycosis.
“I think this approval gives infectious disease practitioners an important new antifungal agent for their armamentarium,” Thomas F. Patterson, MD, chief of the division of infectious diseases at the University of Texas Health Science Center at San Antonio, told Infectious Disease News. “Clearly, the agents we have can be effective, but some patients will have an intolerance to the available drugs or develop serious toxicities. New therapies are needed with good efficacy and safety in this population.”
Cresemba (isavuconazonium sulfate, Astellas Pharma) is the sixth approved antimicrobial product that was designated as a qualified infectious disease product (QIDP). This status is given to agents meant to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) Act. The FDA also granted isavuconazonium sulfate, available in oral and intravenous formulations, orphan drug status.
Thomas F. Patterson
“[The] approval provides a new treatment option for patients with serious fungal infections and underscores the importance of having safe and effective antifungal drugs,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in a press release.
In January, the FDA’s Anti-Infective Drug Advisory Committee unanimously recommended the drug’s approval for invasive aspergillosis, and it also voted 8-2, with one abstention, to recommend isavuconazonium sulfate’s approval for invasive mucormycosis.
The approval for invasive aspergillosis is based on results from the SECURE trial, which included 516 patients randomly assigned to isavuconazonium sulfate or voriconazole. The approval for invasive mucormycosis is based on a single-arm trial of isavuconazonium sulfate involving 37 patients.
Edward Cox
Patterson, who was an investigator for the SECURE trial, credited the QIDP designation of isavuconazonium sulfate for securing the FDA’s approval and for bringing to market a new treatment for invasive fungal infections.
“With mucorales, it would have been very difficult to have a randomized trial to study these infections because of their rarity and really, their severity, and [the QIDP designation] really allows the potential for new drugs, and even new classes of drugs, to be developed to improve outcomes in these patients,” he said.
Disclosure: Patterson reports being a consultant for Astellas while serving on the data review committee in the SECURE trial.