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).
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
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.
Also Read: Cartesian Therapeutics' Rare Disease Candidate Shows Long Lasting Benefit Over Argenx's Vyvgart, Analyst Initiates With Buy.
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.
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.
Earlier this year, at the American Academy of Neurology Annual Meeting, Johnson & Johnson presented data on the molecular properties of nipocalimab.
Last year, the FDA approved UCB SA's (OTC:UCBJF) (OTC: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.
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.
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.
The drug is available in subcutaneous and intravenous injections.
Price Action: JNJ stock is up 0.36% at $164.51 at the last check on Thursday.
- PayPal Supercharges Checkout: New Fiserv Partnership Boosts One-Click Conversions.
Image By Sundry Photography Via Shutterstock
週四，強生公司（紐約證券交易所代碼：JNJ）宣佈向美國食品藥品管理局提交生物製劑許可申請（BLA），尋求在全球範圍內首次批准尼波卡利單抗治療全身性重症肌無力（GmG）。
GmG 是一種自身抗體驅動的神經肌肉疾病，其特徵是肌肉無力波動。
該更新標誌着美國食品藥品管理局首次提交nipocalimab，這是一種具有高親和力和特異性結合的在研藥物，可阻斷fcRN並降低自身抗體水平。
另請閱讀：與Argenx的Vyvgart相比，Cartesian Therapeutics的罕見病候選藥物顯示出長期的益處，分析師首先買入。
該申請包括來自3期Vivacity-MG3研究的數據，該研究表明，與接受安慰劑加SOC的受試者相比，接受nipocalimab加標準護理（SOC）的廣大抗體陽性參與者的預後更好。
在GmG的3期VIVACITY研究中，尼泊卡利單抗達到了主要終點，與安慰劑相比，在第22周至第24周內，MG-ADL評分從基線開始顯著降低。
今年早些時候，在美國神經病學會年會上，強生公司提供了有關尼泊卡利單抗分子特性的數據。
去年，美國食品藥品管理局批准了uCb SA（場外交易代碼：UCBJF）（場外交易代碼：UCBJY）
Rystiggo（rozanolixumab-noli）用於治療抗乙酰膽鹼受體（AchR）或抗肌肉特異性酪氨酸激酶（mUSK）抗體陽性的成年患者的全身性重症肌無力（gMG）。
該公司表示，Rystiggo是唯一獲得美國食品藥品管理局批准的成人抗ACHR和抗麝香抗體陽性gmG的治療方法，這兩種最常見的gmG亞型。
強生公司的藥物還將與Argenx SE（納斯達克股票代碼：ARGX）的Vyvgart Hytrulo競爭，在抗乙酰膽鹼受體抗體陽性的成人患者中獲得轉基因組蛋白。
該藥物有皮下和靜脈注射兩種形式。
價格走勢：在週四的最後一次支票中，JNJ股價上漲0.36％，至164.51美元。
- PayPal爲結賬增值：新的Fiserv合作伙伴關係提高了一鍵轉化率。
圖片由 Sundry 攝影通過 Shutterstock 拍攝
