Fabagal (fabrazyme biosimilar) / ISU Abxis - LARVOL DELTA

Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: ISU Abxis Co., Ltd. | Trial primary completion date: Apr 2024 ➔ Jun 2025

Trial primary completion date • Fabry Disease • Genetic Disorders

Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: ISU Abxis Co., Ltd.

New P3 trial • Fabry Disease • Genetic Disorders

A phase II, multicenter, open-label trial to evaluate the safety and efficacy of ISU303 (Agalsidase beta) in patients with Fabry disease. (PubMed, Medicine (Baltimore)) - "This study showed the efficacy and safety of ISU303. Treatment with ISU303 significantly resulted in plasma and urine Gb3 decrease in patients with FD. These results suggest that ISU303 is safe and effective and can alternative ERT for FD."

Journal • P2 data • Fabry Disease • Genetic Disorders • Pain