Johnson & Johnson Today Announces That The U.S. FDA Has Granted Nipocalimab Breakthrough Therapy Designation For The Treatment Of Adults Living With Moderate-To-Severe Sjögren's Disease, A Debilitating And Chronic Autoantibody Disease With High...
Johnson & Johnson Today Announces That The U.S. FDA Has Granted Nipocalimab Breakthrough Therapy Designation For The Treatment Of Adults Living With Moderate-To-Severe Sjögren's Disease, A Debilitating And Chronic Autoantibody Disease With High...
SPRING HOUSE, Pa., Nov. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren's disease (SjD), a debilitating and chronic autoantibody disease with high prevalence, for which no approved advanced treatments are available.1,2,3,4 Nipocalimab is the only investigational therapy to secure this designation in SjD. This regulatory milestone is the second time BTD has been granted for nipocalimab; the first was granted in February for the treatment of alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).Johnson & Johnson Today Announces That The U.S. FDA Has Granted Nipocalimab Breakthrough Therapy Designation For The Treatment Of Adults Living With Moderate-To-Severe Sjögren's Disease, A Debilitating And Chronic Autoantibody Disease With High Prevalence, For Which No Approved Advanced Treatments Are Available
強生公司今天宣佈，美國FDA已授予Nipocalimab突破性治療指定，用於治療患有中重度乾燥綜合徵的成年人，這是一種令人沮喪且慢性的自身抗體疾病，具有很高的患病率，並且沒有已批准的高級治療方法。
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study
突破性治療指定（BTD）針對調查中的Sjögren病實驗性Nipocalimab，這是一種患有未經批准高級療法的常見自身抗體疾病，該指定得到了來自Phase 2 DAHLIAS研究結果的支持。
A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received placebo
與接受安慰劑的參與者相比，平均接受15毫克/千克Nipocalimab的研究參與者在第24周展示了大於70%的全身疾病活動相對改善。
Nipocalimab was granted BTD in hemolytic disease of the fetus and newborn earlier this year, making this the second time Johnson & Johnson's nipocalimab has received this designation
早些時候，Nipocalimab曾因胎兒及新生兒溶血病獲得BTD，這是強生公司的Nipocalimab第二次獲得該指定。
SPRING HOUSE, Pa., Nov. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren's disease (SjD), a debilitating and chronic autoantibody disease with high prevalence, for which no approved advanced treatments are available.1,2,3,4 Nipocalimab is the only investigational therapy to secure this designation in SjD. This regulatory milestone is the second time BTD has been granted for nipocalimab; the first was granted in February for the treatment of alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).
美國賓夕法尼亞州春田鎮，2024年11月11日/美通社/ - 強生公司（NYSE:JNJ）今天宣佈，FDA已爲患有中重度乾燥綜合徵（SjD）的成年人授予Nipocalimab突破療法指定（BTD），這是一種令人沮喪且慢性的自身抗體疾病，具有很高的患病率，並且沒有已批准的高級治療方法。Nipocalimab是唯一獲得此指定的SjD調查療法。這一監管里程碑是Nipocalimab第二次獲得BTD；首次是在今年2月爲高危群體的接受過敏免疫的孕婦治療胎兒及新生兒嚴重溶血病（HDFN）獲得。
譯文內容由第三人軟體翻譯。
