Healthcare Industry News: U.S. Food and Drug Administration
News Release - January 10, 2018
BYDUREON(R) BCise(TM) Injectable Medicine Now Available In The US For Patients With Type-2 DiabetesWILMINGTON, Del., Jan. 10, 2018 -- (Healthcare Sales & Marketing Network) -- AstraZeneca today announced that BYDUREON® BCise™ (exenatide extended-release) injectable suspension 2mg is now available in pharmacies across the United States. BYDUREON BCise was recently approved by the U.S. Food and Drug Administration for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral antidiabetic medicines in addition to diet and exercise, to improve glycemic control.
BYDUREON BCise is a new formulation of BYDUREON® (exenatide extended-release) injectable suspension 2mg in an improved once-weekly, single-dose autoinjector device. It is designed for patient ease and convenience in a pre-filled device with a pre-attached hidden needle. The new formulation of BYDUREON BCise is proven to reduce blood sugar levels and may have the added benefit of weight loss, although not a weight loss medicine. The medication is administered in three simple steps – mix, unlock, inject.
Rod Wooten, Vice President, Cardiovascular and Metabolic Diseases, AstraZeneca, said: "We're pleased that BYDUREON BCise, a new once-weekly treatment option in an easy-to-use device, is now available for adults with type 2 diabetes. This new formulation helps to provide consistent glycemic control, in addition to the powerful HbA1c reductions and added benefit of weight loss, now in a simply improved device."
Across two clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds were achieved when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral antidiabetic medicines at 28 weeks. The most common adverse reactions reported in =5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%).
Virginia Valentine APRN, BC-ADM, CDE, FAADE, said: "Managing type 2 diabetes is complicated and requires daily attention to meal planning, exercise and medications. A once-weekly prescription option in an easy-to-use device, like BYDUREON BCise, can help simplify a patient's regimen and help them achieve diabetes control goals."
AstraZeneca is committed to supporting patient access to BYDUREON BCise. Eligible commercially insured patients may pay as low as $0 for BYDUREON BCise every month. For more information visit www.BydureonBCise.com.
INDICATION AND LIMITATIONS OF USE
BYDUREON and BYDUREON BCise are both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
- Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis
- Not recommended for use with insulin
- Do not coadminister with other exenatide-containing products
- Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis
WARNING: RISK OF THYROID C-CELL TUMORS
- Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON or BYDUREON BCise cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined
- BYDUREON and BYDUREON BCise are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON or BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON or BYDUREON BCise
- Personal or family history of MTC, patients with MEN 2
- Prior serious hypersensitivity reactions to exenatide or product components
- Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
- Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON or BYDUREON BCise
- Acute Kidney Injury and Impairment of Renal Function Altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with severe renal impairment or end-stage renal disease. Use caution in patients with renal transplantation or moderate renal impairment
- Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)
- Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON- or BYDUREON BCise-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy
- Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON or BYDUREON BCise and promptly seek medical advice
- Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported
- Macrovascular Outcomes No clinical studies establishing conclusive evidence of macrovascular risk reduction with exenatide
- Most common (=5%) and occurring more frequently than comparator in BYDUREON clinical trials: 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%), dyspepsia (5.1%)
- Most common (=5%) in BYDUREON BCise clinical trials: injection-site nodule (10.5%), nausea (8.2%)
- Oral Medications BYDUREON and BYDUREON BCise slow gastric emptying and may reduce the rate of absorption of orally administered drugs
- Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON or BYDUREON BCise
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see full Prescribing Information and Medication Guide for BYDUREON BCISE and full Prescribing Information and Medication Guide for BYDUREON.
NOTES TO EDITORS
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 (CVMD)
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.
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.
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