Posted by Michael Wonder on 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases receive complete response letter for pegunigalsidase alfa from FDA
28 April 2021 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced that they received a complete response letter from the U.S. FDA regarding the biologics license application seeking accelerated approval of pegunigalsidase alfa (PRX‑102) for the proposed treatment of adult patients with Fabry disease.
Protalix and Chiesi are studying the complete response letter to assess the most expedient regulatory approach to reach an understanding with the FDA on additional actions required to obtain approval of PRX‑102, and will provide an update soon.
