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Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
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Isavuconazonium: first global approval.

Paul L McCormack1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand, dru@adis.com.

Drugs
|April 24, 2015
PubMed
Summary
This summary is machine-generated.

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Isavuconazonium, a prodrug of isavuconazole, is now approved for invasive aspergillosis and mucormycosis. This antifungal agent shows promise for treating serious fungal infections.

Area of Science:

  • Medical Mycology
  • Antifungal Drug Development
  • Pharmacology

Background:

  • Isavuconazonium is a water-soluble prodrug of the triazole antifungal isavuconazole.
  • Isavuconazole functions as a 14-α-demethylase inhibitor.
  • The drug is developed by Basilea Pharmaceutica International Ltd and Astellas Pharma Inc.

Purpose of the Study:

  • To summarize the key development milestones of isavuconazonium.
  • To highlight the regulatory journey leading to its first approval.
  • To provide an overview of its therapeutic applications.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval processes.
  • Summary of key efficacy and safety findings.

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Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma
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Main Results:

  • Isavuconazonium received US FDA approval in March 2015 for invasive aspergillosis and mucormycosis.
  • Intravenous and oral formulations are available.
  • The drug is under regulatory review in the EU for these indications.

Conclusions:

  • Isavuconazonium represents a significant advancement in treating invasive fungal infections.
  • The drug's development milestones led to its successful market entry.
  • Ongoing development targets invasive candidiasis and candidaemia.