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AstraZeneca: Update on US regulatory decision for Farxiga in type-1 diabetes

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has issued a complete response letter regarding the
supplemental New Drug Application for Farxiga (dapagliflozin) as an
adjunct treatment to insulin to improve glycaemic control in adult
patients with type-1 diabetes (T1D), when insulin alone does not
provide adequate glycaemic control.

AstraZeneca will work closely with the FDA to discuss the next steps.

Farxiga was recently approved in Europe (5mg) and Japan (5mg,
potential up-titration to 10mg) under the name Forxiga, as an adjunct
to insulin in adults with T1D.

About Farxiga

Farxiga (dapagliflozin) is a first-in-class, oral, once-daily
selective inhibitor of 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. Farxiga has a
robust clinical trial programme of more than 35 completed and ongoing
Phase IIb/III trials with over 35,000 patients, as well as more than
1.8 million patient-years' experience.


The DEPICT (Dapagliflozin Evaluation in Patients with Inadequately
Controlled Type-1 diabetes) clinical trial programme consists of two
clinical trials, DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978),
which are 24-week, randomised, double-blinded, parallel-controlled
trials designed to assess the effects of Farxiga 5mg or 10mg on
glycaemic control in patients with T1D, inadequately controlled by
insulin. All patients were evaluated at week 24 and after a 28-week
extension (52 weeks in total).

About type-1 diabetes

T1D is a chronic disease in which the pancreas produces little or no
insulin. Approximately five per cent of people living with diabetes
have type-1. The condition is caused by an autoimmune reaction that
destroys the beta cells in the pancreas which produce insulin1.
Different factors, including genetics and some viruses, may
contribute to T1D.2

About AstraZeneca in CVRM

Cardiovascular, Renal & Metabolism (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 co-morbidities. 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
( and follow us on Twitter @AstraZeneca

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1. "Diabetes Home." Centers for Disease Control and Prevention,
Centers for Disease Control and Prevention, 15 Aug. 2018,

2. Type 1 Diabetes." Mayo Clinic, Mayo Foundation for Medical
Education and Research, 7 Aug. 2017,


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