AstraZeneca PLC AZ TO PARTICIPATE IN US FDA EMDAC (5201G)
March 04 2015 - 6:54AM
UK Regulatory
TIDMAZN
RNS Number : 5201G
AstraZeneca PLC
04 March 2015
ASTRAZENECA TO PARTICIPATE IN US FDA ENDOCRINOLOGIC AND
METABOLIC DRUGS ADVISORY COMMITTEE
AstraZeneca today announced it will participate in the US Food
and Drug Administration (FDA) Endocrinologic and Metabolic Drugs
Advisory Committee meeting on 14 April 2015 to discuss the results
of the Saxagliptin Assessment of Vascular Outcomes Recorded in
Patients with Diabetes Mellitus (SAVOR) trial for ONGLYZA(R)
(saxagliptin) and Kombiglyze(R) XR (saxagliptin and metformin HCI
extended-release).
The topic of the Advisory Committee is based on an ongoing
review of a previously submitted supplemental New Drug Application
to the FDA for ONGLYZA and Kombiglyze XR.
AstraZeneca welcomes the opportunity to discuss the SAVOR
cardiovascular outcomes data with the Advisory Committee.
About SAVOR
The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded
in Patients with Diabetes Mellitus) clinical trial of Onglyza
(saxagliptin) was a randomised, double-blind, controlled trial
evaluating the effect of saxagliptin on the incidence of major
adverse cardiovascular events in patients with type 2 diabetes
mellitus and at an elevated risk for CV events. The SAVOR study was
conducted as part of the Postmarketing Requirement for the US New
Drug Application approval of Onglyza in accordance with the 2008
FDA guidance, "Diabetes Mellitus - Evaluating Cardiovascular Risk
in New Antidiabetic Therapies to Treat Type 2 Diabetes." The
primary objective of this trial was to determine that the addition
of saxagliptin to standard of care in this patient population did
not significantly increase the incidence of major cardiovascular
events as compared to placebo.
About DPP-4 inhibitors
Saxagliptin belongs to the class of dipeptidyl peptidase-4
(DPP-4) inhibitors. Incretin hormones decrease elevated blood sugar
levels (glucose) by increasing the body's utilisation of sugar,
mainly through increasing insulin production in the pancreas, and
by reducing the liver's production of glucose. DPP-4 inhibitors
work by increasing the activity of the incretin hormones,
increasing the release of insulin when glucose levels are elevated
and reducing the levels of sugar produced by the liver.
About Type 2 Diabetes
Diabetes is estimated to affect 29.1 million people in the US
and more than 382 million people worldwide. The prevalence of
diabetes is projected to reach more than 592 million people
worldwide by 2035. Type 2 diabetes accounts for approximately 90-95
percent of all cases of diagnosed diabetes in the US. Type 2
diabetes is a chronic disease characterised by pathophysiologic
defects leading to elevated glucose levels. Significant unmet needs
still exist, as many patients remain inadequately controlled on
their current glucose-lowering regimen. It is estimated that more
than half of people living with type 2 diabetes are not achieving
recommended HbA1c goals based on guidelines established by
professional societies and advocacy organisations for diabetes
management.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of cardiovascular, metabolic, respiratory, inflammation,
autoimmune, oncology, infection and neuroscience diseases.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.com
CONTACTS
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4 March 2015
- ENDS -
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