Most Recent Events

• 20 Mar 2024 According to an Orchard Therapeutics media release, company announced the details of U.S. commercial launch of Lenmeldy (atidarsagene autotemcel) for the treatment of children early-onset metachromatic leukodystrophy (MLD). The FDA approval of Lenmeldy is based on data from 37 pediatric patients with early-onset MLD, enrolled in two single-arm, open-label clinical studies or treated under European expanded access frameworks.
• 18 Mar 2024 According to an Orchard Therapeutics media release, the FDA approval of Lenmeldy is based on data from 37 pediatric patients with early-onset MLD, enrolled in two single-arm, open-label clinical studies or treated under European expanded access frameworks, who received a one-time administration of the gene therapy and compared with natural history data.
• 18 Mar 2024 The U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel) to Orchard Therapeutics, the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).