The US Food and Drug Administration (FDA) has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for CRESEMBA (isavuconazonium sulfate) as a treatment for fungal infections, including invasive aspergillosis (IA) or invasive mucormycosis (IM) in paediatric patients.
CRESEMBA is a prodrug of the azole antifungal, isavuconazole.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The regulator has set 9 December 2023 as the Prescription Drug User Fee Act goal date for the review of Astellas’ sNDA.
The sNDA is based on results from a Phase II open-label, multicentre, non-comparative study that evaluated the tolerability, safety, efficacy and pharmacokinetics of CRESEMBA.
Astellas’ study enrolled 31 participants aged from one to 17 years diagnosed with IA or IM.
Participants received a loading dose of CRESEMBA intravenously or at the investigator’s discretion, and an oral dose every eight hours on days one and two.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThey were then followed while receiving a once-daily maintenance dose.
Astellas US Medical Specialties business unit head and senior vice-president Lynn Fenicchia stated: “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.
“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 most frequently reported adverse reactions among CRESEMBA-treated patients included nausea (26%), vomiting (25%), diarrhoea (22%), headache (17%) and elevated liver chemistry tests (16%).
The adverse reactions which most often led to permanent discontinuation of therapy during the clinical trials were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea (0.5%), epilepsy (0.5%), respiratory failure (0.5%), and vomiting (0.5%).
