DURATION-7 study results showed significant
HbA1c reduction when BYDUREON was added to insulin glargine therapy
vs insulin glargine alone
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.
IMPORTANT SAFETY INFORMATION
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 causes 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 is 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 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
CONTRAINDICATIONS
- Personal or family history of MTC,
patients with MEN 2
- Prior serious hypersensitivity
reactions to exenatide or product components
WARNINGS AND PRECAUTIONS
- 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
- 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-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
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
ADVERSE REACTIONS
Most common (≥5%) and occurring more frequently than comparator
in 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%), and dyspepsia
(5.1%).
DRUG INTERACTIONS
- Oral Medications BYDUREON slows
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
PREGNANCY
Use during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
INDICATION AND LIMITATIONS OF USE
BYDUREON is 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 mellitus or diabetic
ketoacidosis
- Use with prandial insulin has not been
studied
- 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
Please see 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 (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.
_________________________ 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180403005445/en/
AstraZenecaMichele Meixell, +1 302-885-2677Abigail Bozarth, +1
302-885-2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024