The FDA is asking Sarepta to submit dystrophin data to bolster its NDA for Duchenne muscular dystrophy candidate Promovi.
The data will be derived from 13 already obtained patient biopsies at baseline and week 48, the company said.
Although a correlation has not been made between dystrophin and DMD disease progression, the presence of dystrophin has shown improvements in that patient population. Promovi specifically targets dystrophin production.
Sarepta expects to submit the data to the agency in “the coming weeks.”