AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset Metachromatic Leukodystrophy, Orchard Therapeutics Lenmeldy (atidarsagene autotemcel)
–News Direct–
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics Lenmeldy (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy received approval by the FDA on Monday, March 18.
It is wonderful to see Orchard Therapeutics reach this goal. This accomplishment is a strong proof point of our commitment at AGC Biologics to collaborat...