Empagliflozin

Inventiva announces positive results from the Phase II, LEGEND, Proof-of-Concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and T2D

Retrieved on: 
Monday, March 18, 2024
Diagnosis, Glucose, Histology, Adipose tissue, Arm, Glycated hemoglobin, Type 2 diabetes, Disease, Connective tissue, Steatosis, Insulin, Weight gain, Diabetes, CT1, Patient, Inflammation, SGLT2, Adiponectin, Table, MASH, MD, Liver injury, Insulin resistance, LEGEND, Fibrosis, HDL, Fatty liver disease, Empagliflozin, Safety, Euronext Paris, Phase, NASH, Hepatitis, Lipid metabolism, Prediabetes, Liver disease

Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.

Key Points: 
  • Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.
  • The treatment with lanifibranor 800mg/once daily alone or in combination with empagliflozin for 24 weeks was well tolerated, with no safety concerns reported.
  • The trial is double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm.
  • More details on these results are expected to be presented in upcoming scientific conferences and submitted for publication.

JARDIANCE Market Size, Forecast, and Emerging Insights, 2019-2023 and 2024-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Friday, March 1, 2024
Health, Pharmaceutical, Heart, AMI, EMPOWER, SWOT, EU4, Empagliflozin, Risk, Myocardial infarction, Safety, Acute kidney injury, Patient, SGLT2, Urine, Kidney, Glucose, Kidney disease, Mortality, Research, Pharmaceutical industry

Further, it also consists of future market assessments inclusive of the JARDIANCE market forecast analysis for myocardial infarction in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in myocardial infarction.

Key Points: 
  • Further, it also consists of future market assessments inclusive of the JARDIANCE market forecast analysis for myocardial infarction in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in myocardial infarction.
  • JARDIANCE (Empagliflozin) is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for glucose re-absorption in the kidney.
  • The report also highlights the JARDIANCE research and development activities in myocardial infarction across the United States, Europe and Japan.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of JARDIANCE in myocardial infarction.

IBN Announces Latest Episode of The Bell2Bell Podcast featuring Wa’el Hashad, CEO of Longeveron Inc.

Retrieved on: 
Tuesday, November 14, 2023
Duloxetine, B cell, Longevity, David Berry (inventor), IBN, Ventricular septal defect, Therapy, Boehringer Ingelheim, Patient, HLHS, Hypoplastic left heart syndrome, Eli Lilly, Dabigatran, Eli Lilly and Company, Interview, University, Stem cell, Splenic infarction, Podcast, Amgen, Pharmaceutical industry, Empagliflozin, Evolocumab, Shimaa Hashad

The Bell2Bell Podcast delivers informative updates and exclusive interviews with executives operating in fast-moving industries.

Key Points: 
  • The Bell2Bell Podcast delivers informative updates and exclusive interviews with executives operating in fast-moving industries.
  • Bell2Bell’s latest podcast features Wa’el Hashad, CEO of Longeveron Inc. (NASDAQ: LGVN) , a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty.
  • The latest installment of The Bell2Bell Podcast continues to reinforce IBN’s commitment to the expansion of its robust network of brands, client partners, followers, and the growing IBN Podcast Series .
  • For more than 17 years, IBN has leveraged this commitment to provide unparalleled distribution and corporate messaging solutions to 500+ public and private companies .

Jardiance® recommended for the treatment of adults with chronic kidney disease in the EU

Retrieved on: 
Friday, June 23, 2023
Health, Pharmaceutical, University, Heart failure, Chronic kidney disease, European Medicines Agency, Committee on Herbal Medicinal Products, Type 2 diabetes, Multimedia, SGLT2, Empagliflozin, Committee, EMA, Boehringer Ingelheim, Scientist, LLY, Lilly, Kidney, Committee for Medicinal Products for Human Use, Eli Lilly and Company, EMPA, CKD, Death, NYSE, Kidney disease, CHMP, Pharmaceutical industry, EU, F.A.C.E

“The approval of empagliflozin should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease,” added Co-Principal Investigator Professor Richard Haynes.

Key Points: 
  • “The approval of empagliflozin should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease,” added Co-Principal Investigator Professor Richard Haynes.
  • Empagliflozin demonstrated a significant kidney and cardiovascular benefit in adults with CKD, reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent versus placebo.2,3
    “Across the EU, more than 47 million people are living with chronic kidney disease and even more with cardio-renal-metabolic conditions,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim.
  • “We are very excited about the potential for empagliflozin to play a key role in the management of these interconnected cardio-renal-metabolic conditions.”
    “Cardio-renal-metabolic conditions, like chronic kidney disease, type 2 diabetes and heart failure, are a leading cause of death in Europe.
  • We will continue working closely with regulators worldwide so that adults living with chronic kidney disease, and their health care providers, can benefit from empagliflozin as quickly as possible,” continued Leonard Glass, M.D., F.A.C.E., senior vice president, Diabetes & Obesity Global Medical Affairs, Lilly.

US FDA accepts supplemental New Drug Application for Jardiance® for adults with chronic kidney disease

Retrieved on: 
Friday, January 20, 2023
LLY, Safety, The New England Journal of Medicine, Tablet, Boehringer Ingelheim, III, Medical Affairs Bureau, Standard of care, New Drug Application, Regulation of tobacco by the U.S. Food and Drug Administration, EMPA, Diabetes, ARR, Kidney disease, Cardiovascular disease, Shanda, NYSE, CKD, Heart failure, Type 2 diabetes, Hospital, Kidney, Eli Lilly and Company, FDA, Urine, SGLT2, Chronic kidney disease, EGFR, Patient, Diet, Exercise, Risk, Food, ASN, Dietary supplement, Pharmaceutical industry, Nephrology, Empagliflozin

RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 20, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

Key Points: 
  • RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 20, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
  • Results were presented during the American Society of Nephrology (ASN)'s Kidney Week 2022 and simultaneously published in The New England Journal of Medicine.
  • Jardiance is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
  • In March 2020, the FDA granted Fast Track designation to the clinical investigation of Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD.

Substantial Changes in Management of Patients with Chronic Kidney Disease as New Treatment Options Such as Bayer's Kerendia and SGLT2 Inhibitors Gain Traction in US and EU Markets

Retrieved on: 
Friday, January 20, 2023
RealTime, HIV disease progression rates, UK, Bayer, AstraZeneca, DKD, ARB, MRAS, MRA, PCP, Spironolactone, Kidney, CKD, Health, ACE, Nephrology, Eplerenone, Physician, SGLT2, NASA RealWorld-InWorld Engineering Design Challenge, Novo Nordisk, Patient, Prescription, Diabetic nephropathy, Cowra breakout, Research, Diabetes, Empagliflozin, Pharmaceutical industry, Finerenone, EU

EXTON, Pa., Jan. 20, 2023 /PRNewswire/ -- With SGLT2 inhibitors increasingly becoming the standard of care for diabetic and non-diabetic CKD patients, the broader CKD treatment has begun to change notably.

Key Points: 
  • Of note, while use of mineralocorticoid antagonists (MRAs) – including the newer option Kerendia (Bayer) – has increased over the past year, nephrologists indicate SGLT2 inhibitors remain their most likely first step for patients.
  • Since the approval of Kerendia in July 2021, the use of MRA products overall (inclusive of Kerendia, spironolactone, and eplerenone) in CKD non-dialysis patients has also grown substantially.
  • This research will build off the inaugural research in 2022 of 1,282 patients collected in collaboration with 263 European nephrologists.
  • Results of Spherix's second annual EU chart audit will publish later this spring with notable changes likely to appear.

Phase III trial demonstrated Jardiance is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes

Retrieved on: 
Wednesday, December 7, 2022
Health, Diabetes, Clinical Trials, Research, Pharmaceutical, Science, Lykke, Eli Lilly and Company, Insulin, LLY, Ageing, Exercise, Linagliptin, Pediatrics, International Diabetes Federation, Risk, Adolescence, Empagliflozin, Prevalence, Fasting, Joslin Diabetes Center, NYSE, World Diabetes Day, Diabetes, International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Type 2 diabetes, Obesity, Face, Multimedia, Diet, Metformin, Safety, SGLT2, Harvard Medical School, Boehringer Ingelheim, IDF, New product development, Pharmaceutical industry, Glycated hemoglobin

View the full release here: https://www.businesswire.com/news/home/20221207005405/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221207005405/en/
    The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial included youth aged 10-17 years with type 2 diabetes and HbA1c 6.5% and 10.5%.
  • Participants were randomly assigned treatment with empagliflozin (10 or 25 mg) (n=52), linagliptin (5 mg) (n=53) or placebo (n=53) once daily.
  • Todays results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor empagliflozin compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes.
  • A numerical reduction of 0.34% (P=0.2935) was observed.1
    The findings have been submitted for publication in a peer-reviewed journal.

Drugs Just as Good as Bariatric Surgery in Fight Against Diabetic Kidney Disease, Shows Recent Study Led by My Best Weight Director/University College Dublin's Obesity Specialist

Retrieved on: 
Tuesday, November 15, 2022
Quality of life, Obesity, Interview, Chronic kidney disease, Empagliflozin, Weight loss, Insurance, University College Dublin, Research, Bariatric surgery, Hospital, Patient, University college, Drug combination, Kidney disease, Diabetes, Pharmaceutical industry, Dentistry

DUBLIN, Nov. 15, 2022 /PRNewswire/ -- A new study has shown that improvements in drug treatments for diabetes are just as effective as bariatric surgery in fighting diabetic kidney disease.  Until now, bariatric surgery was established as more effective than drug treatments for patients with obesity and diabetes. However, the new study indicates the evidence has changed as the effectiveness of drug treatments has caught up with surgery.

Key Points: 
  • Until now, bariatric surgery was established as more effective than drug treatments for patients with obesity and diabetes.
  • However, the new study indicates the evidence has changed as the effectiveness of drug treatments has caught up with surgery.
  • The study included 100 patients in Brazil and used the drugs Jardiance and Ozempic with proven benefits for diabetes and chronic kidney disease.
  • Worldwide, nearly 500,000 people undergo bariatric surgery annually, the average cost which ranges from US$7,400 to US$33,000 before insurance coverage.

Despite Amplified Use of SGLT2 Inhibitors for Glomerular Diseases, EU and US Nephrologists Express a Continued Strong Desire for New Treatment Options for FSGS Patients, Spherix Reports

Retrieved on: 
Wednesday, September 21, 2022
Proteinuria, Gaps, Jay Traver, Vifor Pharma, Pulse, Steroid, ESRD, Nephrology, Vertex, Growth, Empagliflozin, Patient, Physician, AstraZeneca, Genetic testing, ACE, Diagnosis, IgA nephropathy, SGLT2, Focal segmental glomerulosclerosis, Research, Awareness, FSGS, ARB, Immunoglobulin A, Nephrotic syndrome, Pharmaceutical industry, EU

EXTON, PA., Sept. 21, 2022 /PRNewswire/ -- Focal segmental glomerulosclerosis (FSGS) is one of the leading causes of nephrotic syndrome across the world and is considered the most common glomerular cause of end-stage renal disease (ESRD).1 Spherix has been tracking the evolution of the FSGS market since 2018 to keep a pulse on how nephrologists are treating patients and the perceived potential for products as they make their way through development.

Key Points: 
  • Over the past few months, Spherix has released two reports revealing insights from both US-based and EU5-based nephrologists as a part of its Market Dynamix: Focal Segmental Glomerulosclerosis (FSGS) research services.
  • Of note, Spherix experts found that while most FSGS patients are still confirmed via kidney biopsies, nephrologists are becoming increasingly likely to use genetic testing for diagnosis.
  • In fact, reported use of SGLT2 inhibitors in primary FSGS patients more than doubled year-over-year in both regions captured in these studies, with expectations for continued growth.
  • To gauge pipeline product potential, Spherix assessed awareness, familiarity, desire to have approved, likelihood to prescribe, and estimated patient candidacy for the following assets:

Primary Care Providers Report a High Unmet Need for New Therapeutic Treatment Options for Chronic Kidney Disease, Despite Earlier Intervention and Referrals to Nephrologists, Spherix Reports

Retrieved on: 
Wednesday, August 10, 2022
FDA, PCP, Chronic kidney disease, HIV disease progression rates, MRA, Kidney disease, DKD, Prescription, Prevalence, SGLT2, Health, Patient, Education, NASA RealWorld-InWorld Engineering Design Challenge, CKD, Hyperphosphatemia, Bayer, Empagliflozin, Nephrology, Anemia, Diabetes, AstraZeneca, Overalls, Disease, Health insurance, Pharmaceutical industry, Akebia

EXTON, Pa., Aug. 10, 2022 /PRNewswire/ -- Approximately 37 million Americans have chronic kidney disease (CKD)—that is one out of every seven U.S. adults.1 Many of these patients are being managed by primary care physicians (PCPs) but are unaware of their kidney disease. In fact, just 10% of people with chronic kidney disease are aware of their condition.2 As such, referrals to nephrologists often vary and are inconsistent across providers.

Key Points: 
  • In fact, just 10% of people with chronic kidney disease are aware of their condition.2 As such, referrals to nephrologists often vary and are inconsistent across providers.
  • The study found that PCPs are often taking the initial critical steps in disease identification and treatment initiation.
  • This is important, as participating PCPs report their own comfort managing CKD patients wanes drastically as their disease advances.
  • When it comes to treatment, PCPs rank CKD within the top three disease areas that have a "high" unmet need for new therapeutic treatment options.