Orchard Therapeutics Announces Swissmedic Validation of the Marketing Authorization Application for Libmeldy (atidarsagene autotemcel)
BOSTON and LONDON, Dec. 01, 2022 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq:ORTX), a global gene therapy leader, today announced its marketing authorization application (MAA) for Libmeldy® (atidarsagene autotemcel) has been accepted for evaluation by the Swiss Agency for Therapeutic Products (Swissmedic) for the potential treatment of eligible patients with early-onset metachromatic leukodystrophy (MLD). The Swiss filing was based on the European Union (EU) MAA for Libmeldy, which was approved by the European Commission in December 2020. Libmeldy is registered in the EU, Iceland, Liechtenstein, Norway and the United Kingdom (UK). The company expects to receive Swissmedic’s assessment report in the first half of 2023.
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