Reported Earlier, Pharming Announces Completion of Enrollment in Pediatric Clinical Trial of Leniolisib
Reported Earlier, Pharming Announces Completion of Enrollment in Pediatric Clinical Trial of Leniolisib
Pharming Group N.V. ("Pharming" or "the Company") (NASDAQ:PHAR) announces the completion of patient enrollment in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).
Leniolisib, marketed under the brand name Joenja in the U.S., received approval from the US Food and Drug Administration (FDA) for the treatment of APDS in adult and pediatric patients 12 years of age and older in March 2023. Pharming plans to include data from this 4–11-year-old trial in regulatory filings worldwide for the approval of leniolisib for pediatric patients with APDS, beginning in 2025.
Pharming Group N.V. ("Pharming" or "the Company") (NASDAQ:PHAR) announces the completion of patient enrollment in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).
Pharming Group N.V.(“藥房” 或 “公司”)(納斯達克股票代碼:PHAR)宣佈其三期臨床試驗(NCT05438407)的患者登記工作已經完成,該試驗評估了在研藥物萊尼奧利西布(一種口服選擇性磷酸肌苷3-激酶 delta)抑制劑,用於 4 至 11 歲活化磷酸肌苷三激酶 delta 綜合徵 (APDS) 的兒童。
Leniolisib, marketed under the brand name Joenja in the U.S., received approval from the US Food and Drug Administration (FDA) for the treatment of APDS in adult and pediatric patients 12 years of age and older in March 2023. Pharming plans to include data from this 4–11-year-old trial in regulatory filings worldwide for the approval of leniolisib for pediatric patients with APDS, beginning in 2025.
Leniolisib在美國以Joenja品牌上市,於2023年3月獲得美國食品藥品監督管理局(FDA)的批准,用於治療12歲及以上的成人和兒童患者的APDS。Pharming計劃從2025年開始將這項歷時4—11年的試驗的數據納入全球監管文件中,以批准雷尼奧利西布用於APDS的兒科患者。
譯文內容由第三人軟體翻譯。
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