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AstraZeneca: The European Medicines Agency accepts regulatory submission for Forxiga in adults with type-1 diabetes

First European filing acceptance of a selective sodium glucose
cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes

AstraZeneca today announced that the European Medicines Agency has
accepted the Marketing Authorisation Variation for Forxiga
(dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral
adjunct treatment to insulin in adults with type-1 diabetes (T1D).

The submission acceptance is based on Phase III data from the DEPICT
(Dapagliflozin Evaluation in Patients with Inadequately Controlled
Type 1 Diabetes) clinical programme for Forxiga in T1D. The
short-term (24 week) and long-term (52 week) data from DEPICT-1,
along with the short-term data from DEPICT-2, showed that
dapagliflozin, when given as an oral adjunct to adjustable insulin in
patients with inadequately-controlled T1D, demonstrated significant
and clinically-relevant reductions from baseline in HbA1c, weight and
total daily insulin dose at 24 and 52 weeks, compared to placebo, at
both 5 mg and 10 mg doses.

The safety profile of dapagliflozin in the DEPICT clinical programme
to date is consistent with its established profile in type-2 diabetes
(T2D), with the exception of a higher number of diabetic ketoacidosis
(DKA) events in dapagliflozin-treated patients versus placebo in
these T1D studies. DKA is a known complication for patients with
diabetes that affects those with T1D more frequently than with T2D.

Forxiga has the potential to become the first selective SGLT-2
inhibitor approved in Europe for the treatment of T1D as an oral
treatment adjunct to insulin, helping to address a significant unmet
need in this patient population. Dapagliflozin is not currently
licensed for use in T1D.

About the DEPICT Clinical Programme

The DEPICT clinical programme consists of two clinical trials,
DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1 and
DEPICT-2 are 24-week, randomised, double-blind, parallel-controlled
trials designed to assess the effects of dapagliflozin 5 mg or 10 mg
on glycaemic control in patients with T1D inadequately controlled by
insulin. All patients will be evaluated at week 24 and after a
28-week extension (52 weeks in total).

About Forxiga (dapagliflozin)

Forxiga is a first-in-class selective inhibitor of human
sodium-glucose co-transporter 2 (SGLT-2 inhibitor) indicated as both
monotherapy and as part of combination therapy to improve glycaemic
control, with the added benefits of blood pressure reductions and
weight loss in adult patients with type-2 diabetes (T2D).

AstraZeneca continues to push the boundaries of science with Forxiga
through the largest and broadest, patient-centric clinical programme.
The DapaCare clinical programme currently will enrol nearly 30,000
patients in randomised clinical trials, include a wide range of
mechanistic studies, and is supported by a multinational real-world
evidence study (CVD-REAL). DapaCare and complimentary clinical
research will generate first-in-class data for Forxiga across a
spectrum of people with T2D, type-1 diabetes (T1D), established CV
disease, CV risk factors and varying stages of renal disease, both
with and without T2D, providing healthcare providers with evidence
needed to improve patient outcomes. DapaCare underscores our
commitment to following the science with Forxiga, as the first SGLT-2
inhibitor to be studied in these diverse patient populations,
pursuing a holistic patient approach to address the multiple risk
factors associated with CV, metabolic and renal diseases.

About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVMD)

Cardiovascular, renal and metabolic diseases together form one of
AstraZeneca's main therapy areas and platforms for future growth. By
following the science to understand more clearly the underlying links
between the heart, kidney 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. Our ambition is to modify or halt the natural course
of CVMDs and even regenerate organs and restore function, by
continuing to deliver transformative science that improves treatment
practices and CVMD 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 & Metabolic Diseases
and Respiratory. The Company also is selectively active in the areas
of autoimmunity, neuroscience and infection. 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.

Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance; Fixed Income; M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology; Other +1 240 477 3771
Christer Gruvris Brilinta; Diabetes +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
US toll free +1 866 381 7277


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