Johnson & Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB
Johnson & Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB
Thursday, Johnson & Johnson (NYSE:JNJ) announced the submission of a Biologics License Application (BLA) to the FDA seeking the first approval of nipocalimab globally for generalized myasthenia gravis (gMG).
週四，強生（紐交所：JNJ）宣佈向FDA提交了一份生物製品申請（BLA），旨在全球範圍內尋求首次批准適應全身性重症肌無力（gMG）的尼泊嘧單抗。
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
gMG是一種由自身抗體驅動的神經肌肉疾病，其特點是肌肉無力的波動性。
The update marks the first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce autoantibody levels.
這個消息標誌着尼泊嘧單抗首次向FDA提交申請，尼泊嘧單抗是一種調查性治療藥物，具有高親和力和特異性的結合能力，可以阻斷FcRn並降低自身抗體水平。
Also Read: Cartesian Therapeutics' Rare Disease Candidate Shows Long Lasting Benefit Over Argenx's Vyvgart, Analyst Initiates With Buy.
還閱讀：Cartesian Therapeutics的罕見疾病候選藥物展示出比Argenx的Vyvgart更持久的效益，分析師以買入開始。
The application included data from the Phase 3 Vivacity-MG3 study, which showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
該申請包括來自第三期Vivacity-MG3研究的數據，該研究顯示接受尼泊嘧單抗加標準護理（SOC）的廣泛抗體陽性參與者與接受安慰劑加SOC的參與者相比，結果更好。
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving a statistically significant reduction in MG-ADL score from baseline over weeks 22 to 24 compared with placebo.
在gMG的第三期VIVACITY研究中，尼泊嘧單抗達到了主要終點，與安慰劑相比，在22至24周的基線MG-ADL評分上取得了統計學上顯著的降低。
Earlier this year, at the American Academy of Neurology Annual Meeting, Johnson & Johnson presented data on the molecular properties of nipocalimab.
今年早些時候，在美國神經學學會年會上，強生公司（紐交所：JNJ）發佈了關於尼泊嘧單抗分子特性的數據。
Last year, the FDA approved UCB SA's (OTC:UCBJF) (OTC:UCBJY)
去年，FDA批准了UCb SA（場外交易：UCBJF）（場外交易：UCBJY）
Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Rystiggo（rozanolixizumab-noli）用於成人患有抗乙酰膽鹼受體（AchR）或抗肌特異性酪氨酸激酶（MuSK）抗體陽性的全身性重症肌無力（gMG）患者。
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
該公司表示Rystiggo是唯一獲得FDA批准用於成人抗AChR和抗MuSk抗體陽性gMG的治療，這是gMG的兩種最常見亞型。
Johnson & Johnson's drug will also compete with Argenx SE's (NASDAQ:ARGX) Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine receptor antibody positive.
強生公司的這種藥物也將與納斯達克上的argenx se（納斯達克股票代碼：argx）的Vyvgart Hytrulo在抗乙酰膽鹼受體抗體陽性的成人gMG患者中競爭。
The drug is available in subcutaneous and intravenous injections.
這種藥物可通過皮下和靜脈注射獲得。
Price Action: JNJ stock is up 0.36% at $164.51 at the last check on Thursday.
股價走勢：JNJ股票在週四最新查詢時上漲了0.36%，報164.51美元。
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Image By Sundry Photography Via Shutterstock
通過shutterstock的Sundry Photography拍攝的圖片
譯文內容由第三人軟體翻譯。