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An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary Angioedema

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Trial Profile

An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary Angioedema

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 12 Jul 2024

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At a glance

  • Drugs Berotralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Acronyms APeX-S
  • Sponsors BioCryst Pharmaceuticals

    • Most Recent Events

    • 09 Jul 2024 According to a BioCryst Pharmaceuticals media release, announced that the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru has granted approval for oral, once-daily ORLADEYO (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.
    • 23 Nov 2023 Results (n=34), assessing safety, effectiveness, and impact on treatment satisfaction in patients who switched from injectable long-term prophylactics (LTPs) to oral berotralstat monotherapy (150 mg daily) at US sites , published in the Annals of Allergy, Asthma and Immunology
    • 08 Sep 2023 According to a BioCryst Pharmaceuticals media release, the Institut national dexcellence en sante et services sociaux (INESSS) has issued a positive recommendation for PrORLADEYO (berotralstat) to be reimbursed for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age and older in Quebec.

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