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AstraZeneca: US FDA approves EPANOVA for the treatment of adults with severe hypertriglyceridaemia

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has approved EPANOVA (omega-3-carboxylic acids) as an adjunct
to diet to reduce triglyceride levels in adults with severe
hypertriglyceridaemia (triglyceride levels greater than or equal to
500 mg/dL).

EPANOVA is the first FDA approved prescription omega-3 in free fatty
acid form. The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams
(4 capsules), making it the first prescription omega-3 to have a
dosing option as few as two capsules once a day, with or without

"The FDA's approval of EPANOVA is good news for the significant and
growing population with severe hypertriglyceridaemia as it offers
physicians and their patients an important new treatment option that
has been proven to be effective in clinical trials," said Briggs
Morrison, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca. "This approval is a significant
milestone for AstraZeneca, as it strengthens our existing portfolio
of cardiovascular medicines. We are committed to further assessing
the clinical profile of EPANOVA and to identifying other patient
groups it may benefit."

Triglycerides are a type of lipid (fat) found in blood and an
essential energy source for the body. Some people have very high
triglyceride levels (severe hypertriglyceridaemia), meaning they have
too much fat in their blood which can lead to serious health
complications. Nearly four million American adults currently have
severe hypertriglyceridaemia and this figure continues to rise, as
the prevalence of associated conditions, such as obesity and
diabetes, continues to grow. EPANOVA is a pure, free fatty acid form
that can provide physicians with an option to effectively manage the
condition without dramatically increasing a patient's pill burden.

The FDA approval was based on data from a clinical development
programme that included positive results from the Phase III EVOLVE
(EpanoVa fOr Lowering Very High triglyceridEs) trial, which examined
the efficacy of EPANOVA in lowering triglycerides and other key lipid
parameters in patients with very high triglycerides. The effect of
EPANOVA on the risk of pancreatitis or on cardiovascular mortality
and morbidity has not been determined.

As part of AstraZeneca's commitment to addressing unmet need in
cardiovascular disease, the company is continuing to evaluate the
clinical profile of EPANOVA. Through a large-scale cardiovascular
outcomes trial, STRENGTH (STatin Residual risk reduction with EpaNova
in hiGh cardiovascular risk paTients with Hypertriglyceridaemia),
AstraZeneca plans to evaluate the safety and efficacy of EPANOVA on
cardiovascular outcomes in combination with statin therapy, in
patients with mixed dyslipidaemia who are at increased risk of
cardiovascular disease. AstraZeneca also plans to pursue the
development of a fixed dose combination of EPANOVA with a statin and
plans to file for regulatory approval in other markets for the severe
hypertriglyceridaemia indication.

- ENDS -


About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit:


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