Author Archives: Diana Campelo Delgado

FDA Extends Review Date to April for US Approval of PRX-102

The U.S. Food and Drug Administration (FDA) has extended the review date by three months — to spring 2021 — for a biologics license application (BLA) seeking accelerated approval of PRX-102 (pegunigalsidase alfa) to treat adults with Fabry disease. Protalix BioTherapeutics and Chiesi Global Rare Diseases, who are…

AVR-RD-01 Gene Therapy Granted Orphan Drug Status in EU

The European Commission has granted orphan drug designation to Avrobio’s investigational gene therapy AVR-RD-01 for the treatment of Fabry disease. The decision, based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency, will provide regulatory and financial incentives for…