FDA approves Protalix/Chiesi's ELFABRIO for Fabry disease in adults

Protalix BioTherapeutics, Inc.

FDA approved ELFABRIO (pegunigalsidase alfa-iwxj) for adult Fabry disease patients.
ELFABRIO is a PEGylated enzyme replacement therapy with a half-life of 78.9 ± 10.3 hours.
More than 140 patients studied; head-to-head trial showed non-inferior efficacy to agalsidase beta in controlling eGFR decline.
Most common adverse reactions (≥15%): infusion reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, sinusitis.
Protalix CEO says approval is a testament to team dedication; Chiesi offers alternative treatment option.

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