US FDA Approves New Easy-to-Use, Once-Weekly BYDUREON® BCise™ Injectable Medicine for Patients with Type-2 Diabetes
October 23 2017 - 7:00AM
Business Wire
New formulation of once-weekly exenatide in
an improved device provides significant HbA1c reduction with added
benefit of weight loss
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has approved BYDUREON® BCise™ (exenatide
extended-release) injectable suspension, a new formulation of
BYDUREON® (exenatide extended-release) injectable suspension in an
improved once-weekly, single-dose autoinjector device for adults
with type-2 diabetes whose blood sugar remains uncontrolled on one
or more oral medicines in addition to diet and exercise, to improve
glycemic control.
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Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists,
BYDUREON BCise has a unique, continuous-release microsphere
delivery system designed to provide consistent therapeutic levels
of the active ingredient, exenatide, to help patients reach and
maintain steady state. The new formulation in the innovative
BYDUREON BCise device is proven to reduce blood sugar levels, with
the added benefit of weight loss, although not a weight loss
medicine.
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
anti-diabetic 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%).
BYDUREON BCise is designed for ease and patient convenience in a
once-weekly, pre-filled device with a pre-attached hidden needle.
The medication is administered in three simple steps – mix, unlock,
inject.
Ruud Dobber, President, AstraZeneca US and Executive Vice
President, North America, said: “We know that physicians have
established longstanding confidence in the significant HbA1c
reduction BYDUREON provides their patients to help achieve
consistent control, with the added benefit of weight loss. With the
approval of BYDUREON BCise, we’re now introducing a new formulation
in an improved, easy-to-use device, that will help enhance the
patient experience.”
BYDUREON BCise will be available for patients in the US in the
first quarter of 2018. BYDUREON Pen will also remain available for
patients. A regulatory application for the new autoinjector device
has also been accepted by the European Medicines Agency.
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
Important Safety Information about BYDUREON and BYDUREON
BCise, including Boxed WARNING
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
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 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
ADVERSE REACTIONS
- 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%)
DRUG INTERACTIONS
- 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
PREGNANCY
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.
– ENDS –
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 programme. This commitment
is advancing 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 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.
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