Trial Profile
PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 28 Dec 2023
Price :
$35
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At a glance
- Drugs Pegzilarginase (Primary) ; Pegzilarginase (Primary)
- Indications Hyperargininaemia
- Focus Registrational; Therapeutic Use
- Acronyms PEACE
- Sponsors Aeglea Biotherapeutics; Spyre Therapeutics
- 22 Dec 2023 According to an Immedica media release, the Medicines & Healthcare products Regulatory Agency in the UK has granted marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D), also known as hyperargininaemia, in adults, adolescents and children aged 2 years and older.
- 27 Nov 2023 According to Spyre Therapeutics media release, Aeglea Biotherapeutics has changed its name to Spyre Therapeutics
- 13 Oct 2023 According to an Immedica media release, based on data from this trial and supported by OLE (CAEB1102-102A), Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in patients two years and older. The positive opinion from the CHMP is now referred to the European Commission for a decision.