US FDA accepts Astellas sNDA for Cresemba to treat invasive aspergillosis or invasive mucormycosis in children

Saturday, August 12, 2023,

Astellas Pharma US, Inc. announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for Cresemba (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal drug, seeking approval for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in paediatric patients aged one to 17 years old. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.

Cresemba is already approved by the FDA for the treatment of IA and IM in adults. If approved for paediatric use, it may offer children significant advances in treatment or may provide a treatment where no adequate therapy exists. IA and IM are a major cause of morbidity and death among immunocompromised and hospitalized paediatric patients.1

"While rare in the general population, invasive aspergillosis or invasive mucormycosis can be incredibly dangerous for immunocompromised children, including those faced with blood and other cancers, and there are very limited treatment options," said Tadaaki Taniguchi, MD, PhD, chief medical officer, Astellas. "The collective efforts by our research and development teams, which have led to the successful sNDA acceptance for Cresemba by the FDA, reflect our ongoing commitment to addressing vulnerable populations with high unmet medical needs."

"Since its approval over eight years ago, Cresemba has been helping adult patients and their physicians fight certain life-threatening fungal infections when they are often critically ill with other diseases," said Lynn Fenicchia, senior vice president and Head of US Medical Specialties Business Unit, Astellas. "This sNDA acceptance by the FDA brings Astellas one step closer to helping paediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved."

The sNDA is based on results from a phase 2 open-label, non-comparative, multicenter study (NCT03816176), evaluating the safety, efficacy and pharmacokinetics of Cresemba for the treatment of IA or IM in pediatric patients aged one to 17 years old. Detailed results will be presented at a future medical meeting.

Invasive aspergillosis can be a life-threatening fungal infection that is seen predominantly in immunocompromised patients, such as patients with leukemia. Invasive mucormycosis is a rare and often life-threatening fungal infection, for which clinical and epidemiological understanding is lacking. Both IA and IM are known for high morbidity and mortality.

Cresemba (isavuconazonium sulfate) is a prodrug of isavuconazole, an azole antifungal drug. Cresemba is indicated for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis.

Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Astellas Pharma US, Inc. is a US affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical conducting business in more than 70 countries around the world. Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. The company is promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on biology and modality.

PHARMABIZ.com