Irish Biopharm Firm Gets Orphan Drug Designation From FDA

Source: PharmaManufacturing.com

Apr 16, 2013

Silicon Republic

Dublin biopharmaceutical company Genable Technologies has been granted orphan drug designation from the Federal Drug Administration (FDA) in the US for its gene therapy product GT308 that it is developing to treat the eye disease retinitis pigmentosa.

The move from the FDA is being regarded by the company as a significant milestone, as it will provide Genable Technologies with seven years' market exclusivity once GT308 has secured regulatory approval. Read the full story here.