Stealth BioTherapeutics Corp. announced that the FDA has granted orphan drug designation to elamipretide for the treatment of Duchenne muscular dystrophy.
The company also announced in a press release that the FDA’s division of neurology has granted a meeting request to discuss a development path for elamipretide in combination with products within the approved therapeutic class of exon-skipping phosphorodiamidate morpholino oligomers.
“We are pleased that the FDA has recognized the high unmet need for innovative treatments for [Duchenne muscular dystrophy],” Stealth CEO