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A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects

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Trial Profile

A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Aug 2024

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At a glance

  • Drugs Isavuconazonium (Primary) ; Isavuconazonium (Primary)
  • Indications Invasive bronchopulmonary aspergillosis; Zygomycosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Astellas Pharma Global Development

Most Recent Events

  • 27 Aug 2024 According to a Basilea Pharmaceutica media release, company announced today that the European Commission (EC) has extended the indications of the antifungal Cresemba (isavuconazole) to pediatric patients and also granted an extension of market exclusivity by two additional years, which triggered a CHF 10 million milestone payment from Basilea's license partner Pfizer Inc. This approval was based on NCT03816176 and NCT03241550 studies.
  • 11 Dec 2023 According to a Basilea Pharmaceutica media release, based on this phase 2 study and the other pediatric clinical study, the Astellas Pharma had received the approval of Cresemba (isavuconazole) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients 1 year of age and older by the US Food and Drug Administration (FDA).
  • 10 Aug 2023 According to an Astellas Pharma media release, detailed results from this trial will be presented at a future medical meeting.

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