AstraZeneca PLC Qtrilmet approved in the EU for treatment of T2D (5476T)
November 15 2019 - 2:00AM
UK Regulatory
TIDMAZN
RNS Number : 5476T
AstraZeneca PLC
15 November 2019
15 November 2019 07:00 GMT
Qtrilmet approved in the EU for the treatment of type-2
diabetes
AstraZeneca today announced that the European Commission (EC)
has approved Qtrilmet (metformin hydrochloride, saxagliptin and
dapagliflozin) modified-release tablets to improve glycaemic
control in adults with type-2 diabetes (T2D).
The approval is based on data from five Phase III trials which
evaluated combinations of Forxiga (dapagliflozin) and Onglyza
(saxagliptin) on a background of metformin in patients with
inadequately controlled T2D. The primary endpoint in these trials
was mean change from baseline in HbA1c (average blood glucose
levels) at week 24 or 52.
Across the trials, the combination of Forxiga, Onglyza and
metformin was superior at reducing HbA1c compared to Forxiga with
metformin, Onglyza with metformin, or glimepiride (an approved T2D
sulphonylurea (SU) medicine) with metformin. The combination of
Forxiga, Onglyza and metformin with or without glimepiride showed
non-inferiority in reducing HbA1c versus the combined use of
insulin and metformin with or without glimepiride. The safety
results of the individual medicines in these trials were consistent
with their known profile.
The EC has approved Qtrilmet to improve glycaemic control in
adults with T2D when metformin with or without SU and either
Onglyza or Forxiga does not provide adequate glycaemic control, or
when T2D patients are already being treated with metformin, Onglyza
and Forxiga.
Qtrilmet was approved in the US in May 2019 under the name
Qternmet XR as an adjunct to diet and exercise to improve glycaemic
control in adults with T2D.
About Qtrilmet
Qtrilmet is a once-daily oral medicine comprised of the
selective sodium--glucose co-transporter 2 (SGLT2) inhibitor
Forxiga, the dipeptidyl peptidase--4 (DPP--4) inhibitor Onglyza and
metformin hydrochloride extended release indicated as treatment in
adults with T2D.
About AstraZeneca in CVRM
Cardiovascular, Renal & Metabolism (CVRM) together forms one
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the Company. By following the science to understand more clearly
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AstraZeneca is investing in a portfolio of medicines to protect
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that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal and
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