Chiesi to take new schedule forward for Fabry disease drug

Italy’s Chiesi has announced the publication of results from the Phase III BRIGHT study of pegunigalsidase alfa 2mg/kg, administered every four weeks for 52 weeks, in adults with Fabry disease who were previously treated with agalsidase alfa or beta, administered every two weeks.

Researchers have concluded that the results show that 2mg/kg of pegunigalsidase alfa, administered every four weeks is well tolerated in adult patients, and that this schedule deserves further exploration.

Pegunigalsidase alfa, sold under the brand name Elfabrio, is a PEGylated α-Gal A enzyme replacement therapy (ERT) that is approved for the treatment of adults with Fabry disease in the USA, European Union and Great Britain at the recommended dose of 1mg/kg of body weight, administered once every two weeks.