AstraZeneca PLC Update on Epanova Phase III STRENGTH trial (5577Z)
13 Gennaio 2020 - 8:00AM
UK Regulatory
TIDMAZN
RNS Number : 5577Z
AstraZeneca PLC
13 January 2020
13 January 2020 07:00 GMT
Update on Phase III STRENGTH trial for Epanova in mixed
dyslipidaemia
Independent Data Monitoring Committee has recommended to
discontinue
the trial as Epanova is unlikely to demonstrate a benefit to
patients
Following the recommendation from an independent Data Monitoring
Committee, AstraZeneca has decided to close the Phase III STRENGTH
trial for Epanova (omega-3 carboxylic acids) due to its low
likelihood of demonstrating a benefit to patients with mixed
dyslipidaemia (MDL) who are at increased risk of cardiovascular
(CV) disease.
STRENGTH is a large-scale, global CV outcomes trial designed to
evaluate the safety and efficacy of Epanova compared to placebo,
both in combination with standard-of-care statin medicines.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "It was important to assess the potential benefit of
Epanova in mixed dyslipidaemia. We are disappointed by these
results, but we remain committed to addressing the needs of
patients in the cardiovascular space where we have an extensive
pipeline."
Steven E. Nissen MD, Study Chair for the STRENGTH trial and
Chief Academic Officer for the Heart and Vascular Institute,
Cleveland Clinic, US, said: "The academic leadership of the
STRENGTH trial is obviously disappointed in this result, but we are
very proud to have had the opportunity to answer this important
scientific question. We are also grateful for the opportunity to
conduct the STRENGTH trial as an exemplary collaboration between
academic physicians and industry."
This trial will now be closed in an orderly fashion, and full
data will be presented at a forthcoming medical meeting.
Financial considerations
A review is being undertaken of the ongoing value of the $533m
Epanova intangible asset. Any impairment will be treated as a
non-Core item in the fourth quarter of 2019. A write down of up to
$100m relating to inventories is also anticipated to impact the
Core earnings in the fourth quarter of 2019.
STRENGTH
STRENGTH is a large-scale CV outcomes trial evaluating the
effect of Epanova 4g daily compared to placebo (corn oil) on
reducing the risk of major adverse cardiovascular events (MACE) in
patients on optimal statin therapy with mixed dyslipidaemia and at
high risk for CV disease. A total of 13,086 patients were enrolled
at 675 sites in 22 countries.
Mixed dyslipidaemia
MDL includes patients with raised triglyceride levels (moderate
hypertriglyceridemia) between 175-499mg/dL mg/dL, and low HDL
cholesterol. Elevated triglycerides affect a growing number of
patients and is often worsened by other factors such as diabetes or
obesity. Lifestyle changes and potentially treating the underlying
cause is likely to at least partly improve the condition and reduce
cardiovascular risk.
Epanova
Epanova is a fish oil-derived mixture of free fatty acids
primarily composed of EPA and DHA. It is approved in the US and
indicated as an adjunct to diet to reduce triglyceride levels in
adult patients with severe (>=500 mg/dL) hypertriglyceridaemia,
and this indication is not impacted by the data from the STRENGTH
trial.
AstraZeneca in CVRM
Cardiovascular, Renal and 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 comorbidities. 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.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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, 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 the Company on Twitter @AstraZeneca.
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