FDA approved Chiesi group And Protalix BioTherapeutics Inc PLX Elfabrio (pegunigalsidase alfa-iwxj) used to treat adults Patients with Fabry disease.
The product is an enzyme replacement therapy for adults with a rare inherited disease in which abnormal deposits of lipids build up, causing pain and sometimes end-organ failure.
Elfabrio is a PEGylated enzyme replacement therapy. It is a recombinant human α-galactosidase A enzyme expressed in plant cell culture and offers a long half-life.
Just last week, the European Commission approved PRX-102 (pegunigalsidase alfa). European Union for Fabry Disease.
Elfabrio competes with Sanofi SA SNY Fabrazyme and Amicus Therapeutics Inc FOLD Galafold in the treatment of Fabry disease.
Almost two years ago, the companies received a Complete Response Letter (CRL) from the FDA in relation to the regulatory filing for pegnigalsidase alfa (PRX-102) for Fabry disease.
Price promotion: PLX shares are up 1.54% at $2.97 at last check on Wednesday.
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