Chiesi Global Rare Diseases and Protalix BioTherapeutics Receives the US FDA’s Approval of Elfabrio (pegunigalsidase alfa-iwxj) for Fabry Disease
Shots:
- The US FDA has approved Elfabrio for the treatment of adults with Fabry disease. The approval was based on a comprehensive clinical development program evaluating Elfabrio in 140+ patients (ERT-naïve & ERT-experienced patients) with up to 7.5 years of follow-up treatment incl. a head-to-head trial
- The trials met its 1EPs & showed that pegunigalsidase alfa was non-inferior to agalsidase beta in controlling eGFR decline, the estimated mean eGFR slope was -2.4 vs -2.3mL/min/1.73 m2/yr., estimated treatment difference was -0.1mL/min/1.73 m2/yr. & was well-tolerated
- Elfabrio is supplied as a preservative-free solution in a single-dose vial while each vial contains 20mg/10mL of pegunigalsidase alfa-iwxj. Treatment is administered by IV infusion, q2w
Ref: Chiesi | Image: Cheisi
Related News:- Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EMA’s CHMP Positive Opinion of Pegunigalsidase Alfa for Fabry Disease
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