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A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema

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Trial Profile

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2024

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At a glance

  • Drugs Berotralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms APeX-J
  • Sponsors BioCryst Pharmaceuticals

Most Recent Events

  • 18 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.
  • 22 May 2023 According to a BioCryst Pharmaceuticals media release, the Public Health Institute (ISP) of Chile has granted marketing authorization for oral, once-daily ORLADEYO (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in patients 12 years of age or older.
  • 12 Jan 2023 Status changed from active, no longer recruiting to completed.

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