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2019-02-01

AstraZeneca: Forxiga receives positive EU CHMP opinion for the treatment of adults with type-1 diabetes

Forxiga is the first oral medicine recommended for approval in Europe
as an adjunct treatment to insulin for adults with type-1 diabetes

The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has recommended a new indication for
the marketing authorisation of Forxiga (dapagliflozin), after
adopting a positive opinion for use as an oral adjunct treatment to
insulin in adults with type-1 diabetes (T1D).

Forxiga, a selective sodium glucose cotransporter-2 (SGLT2) inhibitor,
is the first oral medicine to receive a positive recommendation from
the EMA for use in T1D as an adjunct to insulin in patients with BMI
? 27 kg/m2, when insulin alone does not provide adequate glycaemic
control despite optimal insulin therapy. The positive opinion is
based on Phase III data from the DEPICT (Dapagliflozin Evaluation in
Patients With Inadequately Controlled Type 1-Diabetes) clinical
programme.

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and
Metabolism, BioPharmaceuticals, said: "People with type-1 diabetes
have not seen oral treatment innovation in decades and we believe
today's announcement signals an important advancement for them, as
well as a broader understanding of the well-established clinical
profile of Forxiga for people living with metabolic diseases."

The DEPICT clinical programme consists of two trials, DEPICT-1 and -2,
with the primary efficacy endpoint at 24 weeks and a long-term
extension up to 52 weeks. Both trials demonstrated that Forxiga, when
given as an oral adjunct to adjustable insulin in adults with
inadequately-controlled T1D, showed significant reductions from
baseline in HbA1c (primary endpoint), weight and total daily insulin
dose (secondary endpoints) at 24 and 52 weeks, vs. placebo, at both
5mg and 10mg doses.1,2,3

Forxiga is also under regulatory review in the US and Japan for use as
adjunct treatment to insulin in adults with T1D.

About the DEPICT clinical programme

The DEPICT clinical trial programme consists of two clinical trials:
DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1 and
DEPICT-2 are 24-week, randomised, double-blinded, parallel-controlled
trials designed to assess the effects of Forxiga 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 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 clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials in over
35,000 patients, as well as more than 1.8 million patient-years'
experience.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and 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. Our 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/
(http://www.astrazeneca.com/) and follow us on Twitter
(https://twitter.com/AstraZeneca) @AstraZeneca.

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References

1. Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24-week results from a randomised controlled trial. Lancet Diabetes and Endocrinol. http://dx.doi.org/10.1016/PII. Published Online September 14, 2017.

2. Mathieu C, Dandona, P, Gillard, P, et al. Ef?cacy and Safety of Dapagli?ozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial. Diabetes Care 2018;41:1938-1946.

3. Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: The Depict-1 52-week study. Diabetes Care 2018 Dec; 41(12): 2552-2559.

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