FDA Approves Fabry Disease Treatment from Chiesi, Protalix

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1. FDA approves Elfabrio for Fabry disease treatment by Chiesi and Protalix.

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2. Elfabrio carries a boxed warning for hypersensitivity reactions.

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3. Fabry disease is caused by defective lysosomal α-Galactosidase-A enzyme.

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4. Elfabrio carries a recombinant version of the α-Galactosidase-A enzyme.

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5. Chiesi and Protalix backed Elfabrio’s FDA bid with clinical trial data.

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6. The FDA initially tagged Elfabrio's application for Priority Review.

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7. Elfabrio's initial application was rejected by the FDA in April 2021.

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8. Chiesi and Protalix resubmitted their BLA with more data from clinical trials.

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9. BALANCE is the program's biggest Fabry trial.

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10. Elfabrio is effective in slowing kidney function decline in Fabry patients.

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