Long-term efficacy and safety of pegunigalsidase alfa administered every 4 weeks in adults with Fabry disease: results from up to 5 years of the BRIGHT F51 phase III, open-label extension study - PubM
5 hours ago
- #Fabry disease
- #Enzyme replacement therapy
- #Clinical trial
- Study evaluates long-term efficacy and safety of pegunigalsidase alfa in adults with Fabry disease over up to 5 years.
- Pegunigalsidase alfa was administered every 4 weeks as part of the BRIGHT F51 phase III, open-label extension study.
- The study adhered to ethical guidelines including the Helsinki Declaration and Good Clinical Practice.
- Ethics approval was obtained from multiple international committees.
- Various authors reported conflicts of interest, including grants, consulting fees, and honoraria from pharmaceutical companies.
- References include key literature on Fabry disease and enzyme replacement therapy.