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FDA Approves Astellas' sNDA for the Use of CRESEMBA® (isavuconazonium sulfate) in Children

Friday, August 11, 2023

Astellas Pharma US, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for CRESEMBA® (isavuconazonium sulfate). This application pertains to the use of CRESEMBA, a prodrug of isavuconazole, an azole antifungal drug, for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged one to 17 years old. The FDA has set a target action date of December 9, 2023, under the Prescription Drug User Fee Act (PDUFA).

CRESEMBA is currently approved by the FDA for the treatment of IA and IM in adults. If this sNDA is approved for pediatric use, it could potentially offer a crucial treatment option for children facing these infections, especially when effective therapies are limited. IA and IM are particularly concerning for immunocompromised and hospitalized pediatric patients, often leading to severe health complications and fatalities.

Dr. Tadaaki Taniguchi, Chief Medical Officer at Astellas, emphasized the dangers of these fungal infections for immunocompromised children, particularly those dealing with conditions like blood and other cancers. He also highlighted the limited treatment options available. Dr. Taniguchi expressed appreciation for the collaborative efforts of Astellas' research and development teams, which have led to the successful acceptance of the sNDA for CRESEMBA by the FDA. This achievement underscores Astellas' commitment to addressing the medical needs of vulnerable populations.

Lynn Fenicchia, Senior Vice President and Head of U.S. Medical Specialties Business Unit at Astellas, pointed out that CRESEMBA has played a significant role in treating life-threatening fungal infections in critically ill adult patients for over eight years. The acceptance of the sNDA is a step toward potentially extending this treatment option to a younger patient population, offering a new solution for IA and IM if approval is granted.

The sNDA submission is based on the results of a Phase 2 study (NCT03816176) that evaluated the safety, efficacy, and pharmacokinetics of CRESEMBA in treating IA or IM in pediatric patients aged one to 17 years old. Detailed findings from this study are anticipated to be presented at an upcoming medical conference.

Both invasive aspergillosis and invasive mucormycosis are severe fungal infections. Invasive aspergillosis is often seen in immunocompromised patients, including those with conditions like leukemia. Invasive mucormycosis is a rare and life-threatening fungal infection that lacks comprehensive understanding. Both infections are associated with high morbidity and mortality rates.

CRESEMBA® (isavuconazonium sulfate) is a prodrug of isavuconazole and is currently approved for treating invasive aspergillosis and invasive mucormycosis in patients who are 18 years of age and older. It's recommended to conduct relevant laboratory studies, including fungal cultures and histopathology, before initiating antifungal therapy. However, treatment may commence before obtaining these results, and adjustments should be made based on the findings.

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