Date: 2015-08-14
Type of information: Initiation of preclinical development
phase:
Announcement:
Company: JCR Pharmaceuticals (Japan) GSK (UK)
Product: JR-051 (recombinant alpha-galactosidase A)
Action
mechanism: enzyme replacement therapy/biosimilar.
Disease: Fabry disease
Therapeutic area: Rare diseases - Genetic diseases
Country:
Trial
details:
Latest
news: * On August 14, 2015, JCR Pharmaceuticals announced the results of bioequivalence study of JR-051 (recombinant alpha-galactosidase A), an investigative, enzyme replacement therapy (ERT) for the treatment of Fabry disease, which JCR is developing in collaboration with GSK for Japan and Asia-Oceania territories. The study which began in February 2015, demonstrated the bioequivalence in comparison with an innovator product and the safety of JR-051. The results are based on a randomized, double-blind parallel-group comparative bioequivalence study, comparing the bioequivalence of JR-051 to innovator product, and assessed the safety of JR-051. The results of the study met the predetermined bioequivalence criteria and confirmed that JR-051 is safe in healthy volunteers, with no clinically significant adverse events observed. JCR initiated development of JR-051 as a biosimilar of alpha-galactosidase A. A study to assess the efficacy and safety of JR-051 is being conducted with the aim of filing an application in Japan for marketing authorization of JR-051 in 2017 as a domestically-produced ERT for Fabry disease.
