AstraZeneca announced that the US
Food and Drug Administration (FDA) has approved the BYDUREON Pen
(exenatide extended-release for injectable suspension) 2 mg as an
adjunct to diet and exercise to improve glycaemic control in adults with
type 2 diabetes. BYDUREON should not be used for treatment of patients
with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not
recommended as first-line therapy for patients who have inadequate
glycaemic control on diet and exercise. BYDUREON is not a substitute for
insulin. The concurrent use of BYDUREON with insulin has not been
studied and is not recommended.
BYDUREON is the first and
only once-weekly medicine for adults with type 2 diabetes. The BYDUREON
Pen is a pre-filled, single-use pen injector, eliminating the need for
the patient to transfer the medication between a vial and syringe during
the self-injection process. The BYDUREON Pen contains the same
formulation and dose as the original BYDUREON single-dose tray,
providing the same continuous release of exenatide.
BYDUREON has
been shown to provide powerful HbA1c (blood glucose level) reduction. In
a 24-week, randomised, open-label trial, once-weekly BYDUREON
demonstrated an HbA1c reduction of 1.6 percentage points vs 0.9
percentage points for twice-daily BYETTA (exenatide) injection at 24
weeks (baseline HbA1c 8.5 percent and 8.4 percent, respectively).
Additionally, BYDUREON demonstrated a mean weight reduction of 2.3 kg vs
1.4 kg with BYETTA (baseline 97 kg and 94 kg, respectively). BYDUREON
is not indicated for the management of obesity, and weight change was a
secondary endpoint in clinical trials.
“We’re pleased to receive
approval for the BYDUREON Pen, which can provide a powerful reduction in
blood glucose levels along with the potential benefit of weight loss,
through a once-weekly dose in a pre-filled device,” said Briggs
Morrison, Executive Vice President, Global Medicines Development and
Chief Medical Officer, AstraZeneca. “We are committed to addressing the
needs of adults with type 2 diabetes, including ongoing research to
develop new treatments and methods of delivery.”
The BYDUREON Pen
delivers exenatide via microsphere technology in a once-weekly dose
requiring no titration. It can be administered at any time of the day,
with or without meals.
AstraZeneca plans to make the BYDUREON Pen
available for patients in the US later this year. The BYDUREON
single-dose tray will remain on the market in the US for patients
prescribed BYDUREON.
The FDA approval for BYDUREON was received in
2012. BYDUREON is currently available in 42 countries worldwide,
including European Union countries.
Source: AstraZeneca
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