Editas Medicine (EDIT +0.1%) announced FDA approval of Rare Pediatric Disease designation for EDIT-301, for the treatment of sickle cell disease and plans to file an IND application by the end of 2020.
“We know patients are counting on us, and this designation is a significant milestone for the program that highlights the serious, life-threatening manifestations of sickle cell disease.” said Cynthia Collins, CEO.
Rare Pediatric Disease Designation provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.