By Chris Wack
Protalix BioTherapeutics and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, said Wednesday that the U.S. Food and Drug Administration has approved Elfabrio pegunigalsidase alfa-iwxj in the U.S. for the treatment of adult patients with Fabry disease.
Elfabrio is a PEGylated enzyme replacement therapy.
The companies said the safety, tolerability and efficacy of Elfabrio has been studied in a comprehensive clinical development program in more than 140 patients with up to 7 and one-half years of follow up treatment. Elfabrio was generally well-tolerated with the majority of adverse events being mild or moderate in severity.
In clinical trials, 20 Elfabrio-treated patients experienced hypersensitivity reactions. Four Elfabrio-treated patients experienced anaphylaxis reactions that occurred within 5 to 40 minutes of the start of the initial infusion.
Protalix BioTherapeutics shares were up 14% to $3.32 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
05-10-23 0638ET