Breaking News
July 22, 2018 - Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain
July 22, 2018 - Early supper associated with lower risk of breast and prostate cancer
July 22, 2018 - Survey results identify major inequalities in acute stroke treatment across Europe
July 22, 2018 - Researchers discover promising treatment for genetic form of autism spectrum disorder
July 22, 2018 - Prenatal Depression More Common in Young Moms Today
July 22, 2018 - What helps adults with autism get and keep a job?
July 22, 2018 - Pediatric NEXUS Head CT DI guides selective imaging decisions in blunt trauma patients
July 22, 2018 - Novel tool predicts genes that cause disease due to production of truncated proteins
July 22, 2018 - AHA: Vaping Tied to Blood Clots — in Mice
July 22, 2018 - Study finds therapy dogs effective in reducing symptoms of ADHD
July 22, 2018 - Scientists find reason why malarial parasites are faster than immune cells
July 22, 2018 - Researchers gain more insight into how FUS protein causes ALS and FTLD
July 22, 2018 - Frequency of joint replacements halved in rheumatoid arthritis patients between 1997-2010
July 22, 2018 - QUT researcher highlights growing impact of non-prescription antibiotics supply in pharmacies
July 22, 2018 - UK health communication researcher seeks solutions for disposing leftover medicine
July 22, 2018 - Pfizer Initiates Pivotal Phase 3 Program for Investigational Hemophilia B Gene Therapy Fidanacogene Elaparvovec
July 22, 2018 - Mutation discovered to protect against Alzheimer’s disease in mice
July 22, 2018 - Researchers reveal how patients in urban areas develop multiple, long-term conditions
July 22, 2018 - Replacing conventional cancer treatment with complementary therapy linked to increased risk of death
July 22, 2018 - Study uncovers molecular key for delaying progression of multiple sclerosis
July 22, 2018 - Availability of athletic trainer in high school reduces injury rates in girls’ sports, shows study
July 22, 2018 - FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria
July 22, 2018 - Novel nuclear medicine probe will help assess new drugs for neurodegenerative diseases
July 22, 2018 - Physical activity even during exposure to air pollution can reduce risk of heart attack
July 22, 2018 - Scientists discover protein regulator of myelin production
July 22, 2018 - Sleep disturbances associated with higher dementia risk
July 22, 2018 - Scientists move one step further in developing eye drops to treat age-related macular degeneration
July 22, 2018 - Five-Year Stroke Rates Lower After PCI Versus CABG
July 21, 2018 - Alopecia areata – Genetics Home Reference
July 21, 2018 - Study identifies overdose risk factors in youth with substance use disorders
July 21, 2018 - Drug in clinical trials for Parkinson’s disease offers hope for treating heart failure
July 21, 2018 - Coupling free malaria tests with diagnosis-dependent vouchers can improve rational use of ACTs
July 21, 2018 - Sweetness depends on molecular interactions between specific sugars and water in saliva
July 21, 2018 - Muscle fitness is strongly associated with improved rate of ageing in the brain
July 21, 2018 - Resetting E-Prescriptions for Opioids Helps Curb Use: Study
July 21, 2018 - Overuse of antibiotics not what the doctor ordered
July 21, 2018 - Bundled-payment system did not lower costs for serious medical conditions, shows study
July 21, 2018 - Therapy dogs found to be effective in reducing ADHD symptoms in children
July 21, 2018 - Could rotating multiple therapists better treat PTSD patients?
July 21, 2018 - Binge drinking impairs working memory in adolescent brain
July 21, 2018 - Dying at home could be beneficial for terminally ill cancer patients and their relatives
July 21, 2018 - Researchers identify subtypes of retinal ganglion cells using single-cell RNA sequencing
July 21, 2018 - Study uncovers opportunities to reduce death by suicide among cancer patients
July 21, 2018 - Genetic sequencing reveals new clues to aggressiveness of prostate cancer
July 21, 2018 - BioSight Launches a Phase 2b Clinical Trial of BST-236 as a First-Line Treatment of Acute Myeloid Leukemia
July 21, 2018 - First major study comparing robotic to open surgery published in The Lancet
July 21, 2018 - ADHD medications may fail to improve cognition in healthy college students, study shows
July 21, 2018 - Intervention program that includes a personalized app could benefit teens with suicidal thoughts
July 21, 2018 - Researchers identify new compound that protects against neurodegeneration
July 21, 2018 - Gene therapy may hold potential to treat people with spinal cord injuries
July 21, 2018 - FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 21, 2018 - Surgeons have substantial impact on genetic testing in breast cancer patients who need it
July 21, 2018 - Species diversity can have positive and negative impacts on disease transmission
July 21, 2018 - Genome research suggests presence of enteric fever in medieval Europe
July 21, 2018 - Risk of Sensory Deficits Drops With Rising Gestational Age
July 21, 2018 - Mum’s sleep matters—the effect of sleep on an unborn baby
July 21, 2018 - UC San Diego researchers awarded two grants for investigating stem cell-based therapies
July 21, 2018 - Cellular ‘garbage disposal’ may actually work on some of the proteins to neuronal development
July 21, 2018 - More Pregnant Women Having Heart Attacks
July 21, 2018 - Acne Breakouts | NIH News in Health
July 21, 2018 - Change health messaging to focus on potential impact to help stop the next pandemic
July 21, 2018 - Frailty associated with poor survival rates in young heart patients
July 21, 2018 - New discovery could save millions of lives from fatal fungal infections
July 21, 2018 - OBD presents latest data on the use of EpiSwitch™ in predicting patient response to immunotherapy and identifying lymphoma subtypes
July 21, 2018 - Childhood adversity increases susceptibility to addiction via immune response
July 21, 2018 - Scientists identify potential target for the treatment of binge eating
July 21, 2018 - Whole-brain LIPUS therapy improves cognitive dysfunction in mice simulating dementia, Alzheimer’s
July 21, 2018 - Digital media use raising risk of ADHD symptoms among the young
July 21, 2018 - Phase 3 study of tanezumab in patients with osteoarthritis pain meets all three co-primary endpoints
July 21, 2018 - Restoring mitochondrial function to reverse aging-related skin wrinkles, hair loss in mice
July 21, 2018 - SP PennTech introduces RW-500 rotary vial washer for biotech, pharmaceutical applications
July 21, 2018 - Researchers to study molecular mechanisms behind susceptibility of males to autism
July 21, 2018 - Using tendon transfer surgery to restore key functions in spinal cord injury patient
July 21, 2018 - Scientists create wearable device that measures cortisol in sweat
July 21, 2018 - Researchers study efficacy and safety of new treatment for OUD
July 21, 2018 - Fourth Published Clinical Trial Confirms Long-Term Safety of Niagen Supplementation at High Doses and Shows Potential for Improvement in Liver Health
July 21, 2018 - Study examines effects of a two-day intermittent calorie restriction diet for patients with type 2 diabetes
July 21, 2018 - Greening vacant urban land reduces feelings of depression for surrounding residents
July 21, 2018 - Parents say intense gun violence in PG-13 movies appropriate for teens 15 and older
July 21, 2018 - Collaborative study to assess effects of exercise training for cognitive deficits in MS
FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control

FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control

image_pdfDownload PDFimage_print

April 3, 2018 AstraZeneca today announced the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with inadequate glycemic control. Bydureon is approved for adults with T2D whose blood sugar remains uncontrolled on one or more antidiabetic medicines in addition to diet and exercise, to improve glycemic control.

The expanded use is based on results from the 28-week DURATION-7 study, which examined the effect of Bydureon or placebo as add-on therapy to insulin glargine, with or without metformin, in adults with T2D. Mean HbA1c was reduced by 0.9% in the Bydureon group (n=231) compared to 0.2% in the placebo group (n=229; between-group difference of 0.6%, p<0.001) in patients with a mean baseline HbA1c of 8.5%. Furthermore, 32.5% of patients in the Bydureon group reached an HbA1c of <7.0% compared to 7.0% of patients in the placebo group.

There were no new safety findings in the DURATION-7 study. Overall hypoglycemia was similar between the groups (Bydureon 29.7% and placebo 29.0%), with no reported major hypoglycemia. In both arms, the same percentage of patients reported minor hypoglycemia (5.6%). Like other GLP-1 receptor agonists (RA), the risk of hypoglycemia is increased when Bydureon is coadministered with insulin. Prescribers should consider lowering the dose of insulin when coadministering Bydureon.

The most common adverse events (≥5%) and occurring more frequently than comparator in Bydureon clinical trials are nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%).

Jim McDermott, PhD, Vice President, US Medical Affairs, Diabetes at AstraZeneca, said: “Type 2 diabetes is a complex disease for patients and health care providers to manage, which is why we continue to invest in the advancement of science supporting the safety and efficacy of exenatide, even 13 years after the first exenatide formulation was introduced to the market. The DURATION-7 study is part of the broader DURATION clinical trial program which continues to yield vital insights on the use of exenatide. The Bydureon clinical program is one of the most extensive clinical trial programs of a GLP-1RA to date, having been studied in more than 19,000 patients. With this approval, we are providing another important treatment option for health care providers to consider for patients with type 2 diabetes on basal insulin with inadequate glycemic control.”

Both the American Diabetes Association and the American Association of Clinical Endocrinologists support the use of a GLP-1 RA in combination with basal insulin and metformin in appropriate patients to help manage type 2 diabetes.1,2

Bydureon is a once-weekly GLP-1 RA injectable for adults with type 2 diabetes, intended to help the body produce more insulin in response to an increase in glucose, reduce glucagon production and slow gastric emptying, to assist in reducing hyperglycemia. Bydureon was first approved by the FDA in January 2012.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a main therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. This commitment is advancing the understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination products to help more patients achieve treatment success earlier in their disease.

About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVRM)

Cardiovascular, renal and metabolic diseases together form one of AstraZeneca’s main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in the development of a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMDs and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVMD health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

  1. ADA: American Diabetes Association. Standards of Medical Care in Diabetes–2018. Diabetes Care. 2018;41 (Suppl1):S73-S85.
  2. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2018 executive summary. Endocr Pract. 2018;24(1):91-120.

Source: AstraZeneca

Posted: April 2018

Related Articles:

  • FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes – October 23, 2017
  • FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes – March 3, 2014
  • FDA Approves Bydureon – The First and Only Once-Weekly Treatment for Type 2 Diabetes – January 27, 2012
  • Bydureon FDA Action Date Set for January 28, 2012 – August 10, 2011
  • Bydureon Reply Submitted to FDA – July 28, 2011
  • Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for Bydureon – October 20, 2010
  • Bydureon FDA Review Timeline Set with PDUFA Action Date of October 22, 2010 – May 6, 2010
  • Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for Bydureon – April 23, 2010

Bydureon (exenatide) FDA Approval History

Tagged with:

About author

Related Articles