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news.Advanced Cell Technology (ACT) has received positive opinion for the orphan drug designation for its human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells the treatment of Stargardt's disease from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
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ACT said that this opinion will now be forwarded by the EMA to the European Commission for their adoption, which should follow in coming weeks.
ACT’s interim chairman and CEO Gary Rabin said they are very pleased to receive this positive opinion for Orphan Drug Designation from the EMA for our hESC-derived RPE cells for the treatment of Stargardt’s disease.
"There is currently no approved treatment for Stargardt’s disease, and we are working diligently to move this European trial forward as quickly as possible," Rabin said.