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Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

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Trial Profile

Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2026

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At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Acronyms Bright 51
  • Sponsors Chiesi; Protalix Biotherapeutics

Most Recent Events

  • 05 Jan 2026 According to a Protalix BioTherapeutics media release, a re-examination of the negative opinion issued in November 2025 by the EMA regarding the proposed 2 mg/kg every-four-weeks (E4W) dosing regimen for Elfabrio is underway. An appeal outcome is expected in the Q1 2026.
  • 17 Oct 2025 According to a Chiesi media release, the company acknowledge that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio . The submission for CHMP review was based on data from BRIGHT and its ongoing open label extension study, CLI-06657AA1-03.
  • 09 Sep 2025 According to Chiesi media release, data from the trial were presented at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025, held September 2-6, 2025, in Kyoto, Japan.

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