Orphan Drug Designation filed in EU of Stargardt’s Disease, Advanced Cell Technology (ACTC.OB)
ACTC.OB has filed for Orphan Drug Designation with the European Medicines Agency (EMA) for its Retinal Pigment Epithelial (RPE) Cells for use in treatment of Stargardt’s Macular Dystrophy (SMD), also known as Stargardt’s Disease.
- Orphan drug designation may provide ACT with several advantages, including 10 years of marketing exclusivity for embryonic stem cell derived RPE cells upon market authorization for the indication, financial incentives such as fee reductions or waivers, provide free scientific advice during the drug development process and access to a centralized review process for all 27 member countries.
Earlier this year, ACT received orphan drug designation from the FDA for their SMD program, giving ACTC.OB 7 years of marketing exclusivity in the US.
Degenerative diseases of the retina, which includes Stargardt’s Disease, are among the most common causes of untreatable blindness in the world. As many as 30M people in the United States and Europe suffer from macular degeneration.
Categories: NASDAQ: ACTC.OB, Stem Cell Technology
