PARIS, France and THE WOODLANDS, TX, USA I March 1, 2019 I The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorization of ZynquistaTM* (sotagliflozin), developed by Sanofi and Lexicon.
The CHMP recommended approval of sotagliflozin in the European Union (EU) in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index >= 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2 and SGLT2 is responsible for glucose reabsorption by the kidney.3
The CHMP opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent, significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure and a significant improvement of time in target blood sugar range, versus insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a final decision on the Marketing Authorization Application for sotagliflozin in the EU in the coming months.
Sotagliflozin is also currently being reviewed by the U.S. Food and Drug Administration (FDA) and has the potential to be the first oral antidiabetic drug approved in the U.S. for use together with insulin therapy to improve glycemic control in adults living with T1D. The target FDA action date under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019.8
* The EMA and FDA have conditionally accepted Zynquista(TM) as the trade name for sotagliflozin.
References
- Lapuerta P, et al. Diabetes and Vascular Disease Research. 2015;12(2):101-10, DOI: 10.1177/1479164114563304.
- Hummel CS et al. Am J Physiol Cell Physiol 2011;300(1):C14-C21, DOI: 10.1152/ajpcell.00388.2010.
- Wright EM et al. Physiol Rev 2011;91:733-794.
- Buse JB et al, Diabetes Care 2018 Jun; dc180343. https://doi.org/10.2337/dc18-0343.
- Danne T et al, Diabetes Care 2018 Jun; dc180342. https://doi.org/10.2337/dc18-0342.
- Garg SK et al, N Engl J Med 2017; 377:2337-2348, DOI: 10.1056/NEJMoa1708337.
- Danne T et al. “inTandem1 and inTandem2: increased time in range with sotagliflozin as adjunct therapy to insulin in adults with type 1 diabetes by 24-week continuous glucose monitoring”, Abstract #610, presented at European Association for the Study of Diabetes 54th Annual Meeting, October 1-5, 2018, Berlin, Germany. Available via https://www.easd.org/virtualmeeting/home.html#!resources/intandem1-and-intandem2-increased-time-in-range-with-sotagliflozin-as-adjunct-therapy-to-insulin-in-adults-with-type-1-diabetes-by-24-week-continuous-glucose-monitoring [Accessed February 2019].
- Sanofi press release, “FDA advisory committee votes on Zynquista(TM) (sotagliflozin) as treatment for adults with type 1 diabetes”. Available via http://hugin.info/152918/R/2231739/877460.pdf [Accessed February 2019].
About Lexicon Pharmaceuticals
Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000(TM) program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. |
SOURCE: Sanofi
Post Views: 29
PARIS, France and THE WOODLANDS, TX, USA I March 1, 2019 I The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorization of ZynquistaTM* (sotagliflozin), developed by Sanofi and Lexicon.
The CHMP recommended approval of sotagliflozin in the European Union (EU) in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index >= 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2 and SGLT2 is responsible for glucose reabsorption by the kidney.3
The CHMP opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent, significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure and a significant improvement of time in target blood sugar range, versus insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a final decision on the Marketing Authorization Application for sotagliflozin in the EU in the coming months.
Sotagliflozin is also currently being reviewed by the U.S. Food and Drug Administration (FDA) and has the potential to be the first oral antidiabetic drug approved in the U.S. for use together with insulin therapy to improve glycemic control in adults living with T1D. The target FDA action date under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019.8
* The EMA and FDA have conditionally accepted Zynquista(TM) as the trade name for sotagliflozin.
References
- Lapuerta P, et al. Diabetes and Vascular Disease Research. 2015;12(2):101-10, DOI: 10.1177/1479164114563304.
- Hummel CS et al. Am J Physiol Cell Physiol 2011;300(1):C14-C21, DOI: 10.1152/ajpcell.00388.2010.
- Wright EM et al. Physiol Rev 2011;91:733-794.
- Buse JB et al, Diabetes Care 2018 Jun; dc180343. https://doi.org/10.2337/dc18-0343.
- Danne T et al, Diabetes Care 2018 Jun; dc180342. https://doi.org/10.2337/dc18-0342.
- Garg SK et al, N Engl J Med 2017; 377:2337-2348, DOI: 10.1056/NEJMoa1708337.
- Danne T et al. “inTandem1 and inTandem2: increased time in range with sotagliflozin as adjunct therapy to insulin in adults with type 1 diabetes by 24-week continuous glucose monitoring”, Abstract #610, presented at European Association for the Study of Diabetes 54th Annual Meeting, October 1-5, 2018, Berlin, Germany. Available via https://www.easd.org/virtualmeeting/home.html#!resources/intandem1-and-intandem2-increased-time-in-range-with-sotagliflozin-as-adjunct-therapy-to-insulin-in-adults-with-type-1-diabetes-by-24-week-continuous-glucose-monitoring [Accessed February 2019].
- Sanofi press release, “FDA advisory committee votes on Zynquista(TM) (sotagliflozin) as treatment for adults with type 1 diabetes”. Available via http://hugin.info/152918/R/2231739/877460.pdf [Accessed February 2019].
About Lexicon Pharmaceuticals
Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000(TM) program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. |
SOURCE: Sanofi
Post Views: 29
