AstraZeneca PLC — Regulatory Filings 2019

Jul 1, 2019

6-K 1 a9327d.htm FORXIGA RECEIVES POSITIVE EU CHMP OPINION FOR Document created using Blueprint(R) - powered by Issuer Direct - www.issuerdirect.com Copyright 2019 Issuer Direct Corporation Blueprint

FORM 6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of July 2019

Commission File Number: 001-11960

AstraZeneca PLC

1 Francis Crick Avenue

Cambridge Biomedical Campus

Cambridge CB2 0AA

United Kingdom

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F X Form 40-F __

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

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AstraZeneca PLC

INDEX TO EXHIBITS

1.

Forxiga receives positive EU CHMP opinion for

1 July 2019 07:00 BST

Forxiga receives positive EU CHMP opinion for

DECLARE-TIMI 58 cardiovascular outcomes data

AstraZeneca today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "We are pleased with this positive opinion for the cardiovascular outcomes and renal data for Forxiga and this recommendation acknowledges that even more people with type-2 diabetes could benefit from this medicine."

In DECLARE-TIMI 58, the largest and broadest CV outcomes trial conducted for a SGLT2 inhibitor to date, 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.

DECLARE-TIMI 58 confirmed the well-established safety profile of Forxiga . The trial showed no imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier's gangrene.

Regulatory reviews and submissions are ongoing in several countries, including the US, China and Japan.

About DECLARE-TIMI 58

DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an AstraZeneca-sponsored, 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. 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 DECLARE-TIMI 58 were published in The New England Journal of Medicine in January 2019.

About Forxiga

Forxiga (dapagliflozin) is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) 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 1.8 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, Cardiovascular, Renal & Metabolism, 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 .

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Adrian Kemp

Company Secretary

AstraZeneca PLC

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

AstraZeneca PLC

Date: 01 July 2019

| By: /s/
Adrian Kemp |
| --- |
| Name:
Adrian Kemp |
| Title:
Company Secretary |

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