Posted by Michael Wonder on 09 Oct 2020
Italfarmaco receives FDA rare paediatric disease designation for givinostat in Duchenne muscular dystrophy, announces completed enrolment in EPIDYS Phase 3 trial
9 October 2020 - The Italfarmaco Group provided today an update on the development of givinostat, its proprietary histone deacetylase inhibitor, in boys with Duchenne muscular dystrophy.
The U.S. FDA granted a rare paediatric disease designation to givinostat for the treatment of Duchenne muscular dystrophy, which allows an expedited review process for new treatment modalities.
The company also announced the completion of patient enrolment in the EPIDYS Phase 3 trial on 25 September 2020 and remains on track with its proposed timelines for reporting top-line data in June 2022.
