AZ TO PARTICIPATE IN US FDA EMDAC

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 ® (saxagliptin) and Kombiglyze ® 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 ( S axagliptin A ssessment of V ascular O utcomes R ecorded 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.

Ab out 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

Media Enquiries

Esra Erkal-Paler                         +44 20 7604 8030 (UK/Global)

Vanessa Rhodes                        +44 20 7604 8037 (UK/Global)

Ayesha Bharmal                         +44 20 7604 8034 (UK/Global)

Jacob Lund                                 +46 8 553 260 20 (Sweden)

Michele Meixell                            + 1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen               +44 20 7604 8199    mob: +44 7818 524185       

Karl Hård                                     +44 20 7604 8123    mob: +44 7789 654364

Craig Marks                                +44 20 7604 8591    mob: +44 7881 615764

Eugenia Litz                                +44 20 7604 8233    mob: +44 7884 735627

Christer Gruvris                          +44 20 7604 8126    mob: +44 7827 836825

4 March 2015

- ENDS -

About Us

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com

Subscribe

Documents & Links