Kyowa buyout Orchard wins FDA nod for rare disease therapy [Seeking Alpha]
KIRIN HLDGS CO LTD S/ADR (KNBWY)
US:NASDAQ Investor Relations:
kirinholdings.co.jp/english/ir
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Source: Seeking Alpha
FDA-approved treatment for early-onset metachromatic leukodystrophy (MLD), a rare metabolic disorder. Formerly known as OTL-200, Lenmeldy is designed to add copies of the human arylsulfatase-A (ARSA) gene, mutations of which lead to MLD. According to the FDA labeling information, the treatment will be indicated in the U.S. for children with MLD during pre-symptomatic to early symptomatic stages, who had no disease-specific therapeutics previously. "The FDA approval of Lenmeldy opens up tremendous new possibilities for children in the U.S. with early-onset MLD who previously had no treatment options beyond supportive and end-of-life care," Orchard's CEO, Bobby Gaspar, remarked. Orchard (ORTX) plans to announce details about Lenmeldy's market rollout this week. The approval came weeks after the Japanese drugmaker Kyowa Kirin ( OTCPK:KYKOF ) acquired the British company in January for $387.4M. Recommended For You More Trending News Recommended For You More Trending News
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