Label updated with positive cardiovascular outcomes and renal data from the DECLARE-TIMI 58 trial
[caption id="attachment_9277" align="aligncenter" width="747"]
Press Release[/caption]
AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for?Forxiga?(dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: ?For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke. In the?Phase III?DECLARE-TIMI 58 trial,?Forxiga?reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type-2 diabetes, and we look forward to bringing these?additional?benefits?of the medicine?to people with type-2 diabetes in?the EU.?
In the Phase III DECLARE-TIMI 58 trial,?Forxiga?achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints. There were fewer major adverse CV events observed with?Forxiga?for the other primary efficacy endpoint, however this did not reach statistical significance.
The Phase III DECLARE-TIMI 58 trial confirmed the well-established safety profile of?Forxiga. The trial showed no significant imbalance with?Forxiga?versus placebo in amputations, fractures, bladder cancer or Fournier?s gangrene.
Inclusion of the DECLARE-TIMI 58 trial data to the medicine?s?label?is currently under regulatory review in the US and China.
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is the largest CV outcomes trial conducted for a selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) to date in a broad patient population. It is an AstraZeneca-sponsored, Phase III, randomised, double-blinded, placebo-controlled, multicentre trial, designed to evaluate the effect of?Forxiga?compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease and also assessed key renal secondary endpoints. The trial included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, US) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).
The full results of the?DECLARE-TIMI 58?trial were published in?The New England Journal of Medicine?in January 2019.
About?Forxiga
Forxiga?(dapagliflozin) is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D.?Forxiga?has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years? experience.
About AstraZeneca in CV, Renal & Metabolism (CVRM)
CVRM together forms one of AstraZeneca?s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling comorbidities. The Company?s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit?astrazeneca.com?and follow us on Twitter?@AstraZeneca.
Press Release[/caption]
AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for?Forxiga?(dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: ?For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke. In the?Phase III?DECLARE-TIMI 58 trial,?Forxiga?reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type-2 diabetes, and we look forward to bringing these?additional?benefits?of the medicine?to people with type-2 diabetes in?the EU.?
In the Phase III DECLARE-TIMI 58 trial,?Forxiga?achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints. There were fewer major adverse CV events observed with?Forxiga?for the other primary efficacy endpoint, however this did not reach statistical significance.
The Phase III DECLARE-TIMI 58 trial confirmed the well-established safety profile of?Forxiga. The trial showed no significant imbalance with?Forxiga?versus placebo in amputations, fractures, bladder cancer or Fournier?s gangrene.
Inclusion of the DECLARE-TIMI 58 trial data to the medicine?s?label?is currently under regulatory review in the US and China.
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is the largest CV outcomes trial conducted for a selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) to date in a broad patient population. It is an AstraZeneca-sponsored, Phase III, randomised, double-blinded, placebo-controlled, multicentre trial, designed to evaluate the effect of?Forxiga?compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease and also assessed key renal secondary endpoints. The trial included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, US) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).
The full results of the?DECLARE-TIMI 58?trial were published in?The New England Journal of Medicine?in January 2019.
About?Forxiga
Forxiga?(dapagliflozin) is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D.?Forxiga?has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years? experience.
About AstraZeneca in CV, Renal & Metabolism (CVRM)
CVRM together forms one of AstraZeneca?s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling comorbidities. The Company?s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit?astrazeneca.com?and follow us on Twitter?@AstraZeneca.
Contacts
Media Relations |
||
| Gonzalo Vi?a | +44 203 749 5916 | |
| Rob Skelding | Oncology | +44 203 749 5821 |
| Rebecca Einhorn | Oncology | +1 301 518 4122 |
| Matt Kent | BioPharma | +44 203 749 5906 |
| Jennifer Hursit | Other | +44 203?749 5762 |
| Christina Malmberg H?gerstrand | Sweden | +46 8?552 53 106 |
| Michele Meixell | US | +1 302 885 2677 |
Investor Relations |
||
| Thomas Kudsk Larsen | +44 203 749 5712 | |
| Henry Wheeler | Oncology | +44 203 749 5797 |
| Christer Gruvris | BioPharma (cardiovascular; metabolism) | +44 203 749 5711 |
| Nick Stone | BioPharma (respiratory; renal) | +44 203 749 5716 |
| Josie Afolabi | Other medicines | +44 203 749 5631 |
| Craig Marks | Finance; fixed income | +44 7881 615 764 |
| Jennifer Kretzmann | Corporate access; retail investors | +44 203 749 5824 |
| US toll-free | +1 866 381 72 77 |
Adrian Kemp
Company Secretary
AstraZeneca PLC
