FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication
FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication
On Wednesday, the FDA approved Incyte Corporation (NASDAQ:INCY) and Syndax Pharmaceuticals Inc's (NASDAQ:SNDX) Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients.
FDA於週三批准了Incyte股份有限公司(NASDAQ:INCY)和Syndax Pharmaceuticals Inc. (NASDAQ:SNDX)的Niktimvo (axatilimab-csfr)，這是一種抗-CSF-1R抗體，用於治療在成人和兒童患者中至少兩種全身治療失敗後的慢性移植物抗宿主病(GVHD)。
"Niktimvo is Incyte's second approved treatment for chronic GVHD," said Hervé Hoppenot, CEO, Incyte.
"Niktimvo是Incyte治療慢性GVHD的第二種批准藥物，"Incyte的CEO Hervé Hoppenot說。
Chronic GVHD is a serious condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor). The donated cells initiate an immune response and attack the transplant recipient's organs.
慢性GVHD是在異基因幹細胞移植（從供體中轉移幹細胞）後可能發生的嚴重疾病。捐贈的細胞會引發一個免疫反應並攻擊移植接受者的器官。
Also Read: Incyte's Q2 Earnings: Wider Than Expected Loss, Pipeline Review, Lifts Jakafi Sales Guidance.
此外還閱讀：Incyte的第二季度業績：虧損高於預期，管線評估，推動Jakafi銷售指南。
Chronic GVHD is estimated to develop in approximately 42% of transplant recipients, affecting approximately 17,000 patients in the U.S.
據估計，慢性GVHD在約42%的移植受體中發生，影響美國約17,000名患者。
The FDA approval was based on data from the global AGAVE-201 study of Niktimvo in 241 adult and pediatric patients with refractory chronic GVHD who received at least two prior lines of systemic therapy.
FDA批准是基於全球AGAVE-201對Niktimvo的研究數據，該研究共納入了241名接受過至少兩種全身治療且難治性慢性GVHD的成人和兒童患者。
The trial met the primary endpoint across all cohorts receiving Niktimvo. The study showed durable responses across all organs studied and patient subgroups.
該試驗在接受Niktimvo的所有組（cohort）中均達到了主要終點。該研究顯示了所有研究的器官和患者亞組均有持久的反應。
Among patients who received Niktimvo at the approved dose of 0.3 mg/kg every two weeks (N=79), 75% achieved an overall response rate (ORR) within the first six months of treatment, with a median time to response of 1.5 months.
在接受批准劑量爲0.3mg/kg每兩週注射Niktimvo的患者(共79例)中，75%的患者在治療的前六個月內實現了總體響應率(ORR)，平均反應時間爲1.5個月。
In the U.S., Niktimvo will be co-commercialized by Incyte and Syndax Pharmaceuticals.
在美國，Niktimvo將由Incyte和Syndax Pharmaceuticals共同商業化。
Incyte has exclusive commercialization rights for Niktimvo outside of the U.S.
除美國外，Incyte擁有Niktimvo的獨家商業化權利。
To facilitate patient dosing and limit product waste, Incyte and Syndax will seek approval to launch two smaller vial sizes following the FDA's approval of Niktimvo (as a 50mg vial).
爲了方便患者用藥和限制產品浪費，Incyte和Syndax將在FDA批准Niktimvo（爲50毫克/瓶）後申請推出兩種小瓶規格。
Following FDA approval of the new vial sizes, the companies anticipate launching Niktimvo in the U.S. no later than the early first quarter of 2025.
在FDA批准新瓶規格後，兩家公司預計最早於2025年初在美國推出Niktimvo。
Price Action: INCY stock is trading higher by 1.26% to $61.95, and SNDX stock is up 1.84% at $19.94 at the last check on Thursday.
價格行動：週四最後檢查時，INC股票以1.26%的漲幅報61.95美元，SNDX股票以1.84%的漲幅報19.94美元。
譯文內容由第三人軟體翻譯。