Zynquista:FDA拒絕賽諾菲1型糖尿病藥物Zynquista新藥批准

FDA拒絕賽諾菲1型糖尿病藥物Zynquista新藥批准

FDA拒絕賽諾菲1型糖尿病藥物Zynquista新藥批准

2019年3月25日—Zynquista是葡萄糖蛋白質通道SGLT-1和SGLT-2的口服雙重抑製劑,這些蛋白質影響腸道和腎中的葡萄糖吸收。本次NDA基於...。其他文章還包含有:「Zynquista」、「Zynquista」、「LexiconprepsFDAresubmissionfordiabeteshopeful...」、「LexiconplansanotherbidforZynquistaintype1diabetes」、「Zynquista(sotagliflozin)」、「Sotagliflozin」、「Sotagliflozin」、「賽諾菲口服糖尿病藥物sotagliflozin上市申請...

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撰文記者薛瀹熢日期2019-03-25FDA拒絕賽諾菲1型糖尿病藥物Zynquista新藥批准(圖片來源:網路)美國時間22日,FDA回絕了法國製藥公司賽諾菲(Sanofi)與Lexicon共同合作的實驗性1型糖尿病藥物Zynquista™(sotagliflozin)。該藥物是SGLT-1/SGLT-2抑制劑。賽諾菲目前並未對此多做解釋,不過FDA拒絕此藥物的理由主要應該是基於安全性與有效性考量,Zynquista有可能增加糖尿病酮酸中毒風險。Zynquis...

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Zynquista
Zynquista

https://www.ema.europa.eu

Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ? 27 ...

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Zynquista
Zynquista

https://www.ema.europa.eu

Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ...

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Lexicon preps FDA resubmission for diabetes hopeful ...
Lexicon preps FDA resubmission for diabetes hopeful ...

https://www.fiercepharma.com

Lexicon is hoping for an approval that clears the drug to be used as an add-on to insulin therapy for adults with Type 1 diabetes mellitus and ...

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Lexicon plans another bid for Zynquista in type 1 diabetes
Lexicon plans another bid for Zynquista in type 1 diabetes

https://www.pharmaceutical-tec

Lexicon's Zynquista (sotagliflozin) is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).

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Zynquista (sotagliflozin)
Zynquista (sotagliflozin)

https://www.drugs.com

Zynquista (sotagliflozin) is a dual sodium-glucose co-transporter-1 and -2 inhibitor in development as an adjunct to insulin therapy for ...

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Sotagliflozin
Sotagliflozin

https://pubmed.ncbi.nlm.nih.go

Sotagliflozin (Zynquista™) is the first dual inhibitor of sodium-glucose co-transporter-1 and -2 (SGLT1 and 2). In the phase 3, inTANDEM 1-3 trials ...

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Sotagliflozin
Sotagliflozin

https://en.wikipedia.org

Sotagliflozin was approved for medical use in the European Union in April 2019, as Zynquista, for the treatment for type 1 diabetes, and in the United States in ...

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賽諾菲口服糖尿病藥物sotagliflozin上市申請被美國FDA拒絕
賽諾菲口服糖尿病藥物sotagliflozin上市申請被美國FDA拒絕

https://ibmi.taiwan-healthcare

3月23日,賽諾菲與合作夥伴Lexicon宣佈其SGLT1/2雙抑制劑sotagliflozin(商品名Zynquista)用於治療成人一型糖尿病的上市申請被美國FDA拒絕,但具體原因 ...

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Sotagliflozin
Sotagliflozin

https://pubmed.ncbi.nlm.nih.go

Sotagliflozin (Zynquista™) is a dual inhibitor of sodium-glucose co-transporters (SGLT) 1 and 2 being developed by Lexicon Pharmaceuticals and Sanofi as a ...