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).
Pharming Group N.V.（“药房” 或 “公司”）（纳斯达克股票代码：PHAR）宣布其三期临床试验（NCT05438407）的患者登记工作已经完成，该试验评估了在研药物莱尼奥利西布（一种口服选择性磷酸肌苷3-激酶 delta）抑制剂，用于 4 至 11 岁活化磷酸肌苷三激酶 delta 综合征 (APDS) 的儿童。
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在美国以Joenja品牌上市，于2023年3月获得美国食品药品监督管理局（FDA）的批准，用于治疗12岁及以上的成人和儿童患者的APDS。Pharming计划从2025年开始将这项历时4—11年的试验的数据纳入全球监管文件中，以批准雷尼奥利西布用于APDS的儿科患者。
译文内容由第三方软件翻译。