AstraZeneca PLC Update on US regulatory decision for Farxiga (4974F)
July 15 2019 - 2:00AM
UK Regulatory
TIDMAZN
RNS Number : 4974F
AstraZeneca PLC
15 July 2019
15 July 2019 07:00 BST
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.
About DEPICT
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
insulin.(1) 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
astrazeneca.com and follow us on Twitter @AstraZeneca.
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References
1. "Diabetes Home." Centers for Disease Control and Prevention,
Centers for Disease Control and Prevention, 15 Aug. 2018,
www.cdc.gov/diabetes/basics/type1.html.
2. Type 1 Diabetes." Mayo Clinic, Mayo Foundation for Medical
Education and Research, 7 Aug. 2017,
www.mayoclinic.org/diseases-conditions/type-1-diabetes/symptoms-causes/syc-20353011.
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