AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset MLD, Orchard Therapeutics’ Lenmeldy™

AGC Biologics Milan site now has clearances from both U.S. and European regulators to supply patients with HSC-based gene therapy using approved commercial processes

Today, we announced that the U.S. Food and Drug Administration (FDA) has cleared our 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 collaborating directly with developers to meet rigorous regulatory standards and achieve the best possible results for our partners,” says Patricio Massera, CEO of AGC Biologics.  

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