UPDATE 1-US approves first gene therapy for children with rare genetic disease [Yahoo! Finance]
KIRIN HLDGS CO LTD S/ADR (KNBWY)
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Source: Yahoo! Finance
Therapeutics' gene therapy to treat children with metachromatic leukodystrophy (MLD), making it the first approved treatment in the United States for the rare, hereditary disease. Orchard, which was acquired by Japanese pharmaceutical firm Kyowa Kirin for $477.6 million last year, said it will provide details on the pricing and availability of the therapy later in the week. The one-time therapy, branded as Lenmeldy in the U.S., is approved for children in certain stages of disease progression, the Food and Drug Administration (FDA) said. The approval was based on data from 37 children who received Lenmeldy in two open-label clinical trials, whose results showed that the therapy significantly reduced the risk of severe motor impairment or death compared with untreated children. The regulator also flagged potential risk of blood cancer associated with the treatment, along with formation of blood clots or a type of swelling of brain tissues. MLD, which affects the brain and ner
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