AstraZeneca PLC Qtrilmet recommended for approval in EU by CHMP (2444N)
September 23 2019 - 2:01AM
UK Regulatory
TIDMAZN
RNS Number : 2444N
AstraZeneca PLC
23 September 2019
23 September 2019 07:00 BST
Qtrilmet recommended for approval in EU by
CHMP for the treatment of type-2 diabetes
AstraZeneca today announced that Qtrilmet (metformin
hydrochloride, saxagliptin and dapagliflozin) modified-release
tablets have been recommended for marketing authorisation in the
European Union for the treatment of adults with type-2 diabetes
(T2D).
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion 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 in reducing HbA1c versus Forxiga combined
with metformin, Onglyza combined with metformin, or glimepiride
combined with metformin. The combination of Forxiga, Onglyza and
metformin with or without sulphonylurea (SU) was non-inferior to
the combined use of insulin and metformin with or without SU in
reducing HbA1c.
The safety results of the individual medicines in these trials
were consistent with their known profile.
The CHMP recommended the marketing authorisation for Qtrilmet to
improve glycaemic control when metformin with or without SU and
either saxagliptin or dapagliflozin does not provide adequate
glycaemic control, or when T2D patients are already being treated
with metformin, saxagliptin and dapagliflozin.
Qtrilmetis approved in the US under the name Qternmet XR as an
adjunct to diet and exercise to improve glycaemic control in adults
with T2D.
About Qtrilmet
Qtrilmetis 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
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 and
Metabolism (CVRM) and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow us on
Twitter @AstraZeneca.
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