Kyowa Kirin and Orchard Therapeutics Announce OTL-200 Granted Orphan Regenerative Medicine Product Designation for Early-onset MLD in Japan
KIRIN HLDGS CO LTD S/ADR (KNBWY)
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Source: GlobeNewswire
TOKYO, LONDON and BOSTON, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd., (TSE: 4151, President and COO: Abdul Mullick, "Kyowa Kirin") and Orchard Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Regenerative Medicine Product Designation to OTL-200, also known as atidarsagene autotemcel, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ), and early-symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD). MLD is an ultra-rare, rapidly progressive, irreversible and ultimately fatal neurometabolic disease that affects approximately one in 100,000 live births based on existing literature. It is caused by an error in the gene responsible for encoding the enzyme arylsulfatase A (ARSA) leading to neurological damage and developmental regression. In the
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