FDA granted a novel recombinant enzyme from Linno with “Orphan Drug Designation” (ODD) status for treatment of metachromatic leukodystrophy (MLD)
2023-12-18
FDA granted a novel recombinant enzyme from Linno with “Orphan Drug Designation” (ODD) status for treatment of metachromatic leukodystrophy (MLD), a devastating inherited genetic disease that causes unmatured death of the affected pediatric patients. Such product has been developed upon Linno-developed proprietary technology for BBB-crossing drug delivery, which has been validated with multiple modalities as fusions with peptide, protein, enzyme, antibody fragment as well as conjugation with siRNA. Patent applications for the technology and associated products had been summited to China, US and EU under a PCT umbrella.