# AstraZeneca Brilinta approved in the US by FDA

- Link: https://www.directorstalkinterviews.com/astrazeneca-brilinta-approved-in-the-us-by-fda/412827451
- Published: 2020-06-01T07:32:29+01:00
- Author: Amilia Stone

**[AstraZeneca PLC](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Brilinta_ (ticagrelor) has been approved in the US to reduce the risk of a first
heart attack or stroke in high-risk patients with coronary artery disease (CAD),
the most common type of heart disease.

The approval by the US Food and Drug Administration (FDA) was based on positive 
results from the Phase III THEMIS trial. The trial showed a statistically significant
reduction in the primary composite endpoint of major adverse cardiovascular (CV)
events at 36 months with aspirin plus _Brilinta_ 60mg versus aspirin alone in patients
with CAD and type-2 diabetes (T2D) at high-risk of a first heart attack or stroke.
^(1) The primary composite endpoint was driven by a reduction in heart attack and
stroke_._

This is the first regulatory approval for aspirin plus _Brilinta_ dual antiplatelet
therapy in patients who have a high CV risk, but without a history of heart attack
or stroke.

> **Deepak L. Bhatt, MD, MPH, THEMIS trial Co-Chair, Executive Director of Interventional
> Cardiovascular Programs at Brigham and Women’s Hospital, and Professor of Medicine
> at Harvard Medical School, Boston, US said**: “Coronary artery disease is a potentially
> life-threatening condition that causes significant morbidity in many people. The
> addition of ticagrelor to aspirin offers a new therapeutic option to decrease 
> the likelihood of both heart attack and stroke, a significant advance in our ability
> to treat these high-risk patients.”

> **Gabriel Steg, MD, THEMIS trial Co-Chair and Professor at Université de Paris,
> said:** “THEMIS for ticagrelor was a large, multi-national trial of more than 
> 19,000 patients with coronary artery disease and type-2 diabetes. Around one third
> of patients with coronary artery disease have type-2 diabetes, putting them at
> higher risk of heart attack or stroke, than patients without diabetes. Today’s
> approval brings new hope to patients at risk of experiencing a first heart attack
> or stroke.”

> **Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said:**“
> Today’s approval of _Brilinta_ is important news for patients with coronary artery
> disease who will now have a new therapy option to reduce the risk of a first heart
> attack or stroke. This new indication is a further testament to the overwhelming
> science supporting _Brilinta_ in the management of patients with coronary artery
> disease at high risk for cardiovascular events.”

The THEMIS trial demonstrated the relative risk reduction of the composite endpoint
of heart attack, stroke and CV death by 10% (absolute risk reduction; 0.8%, 7.7%
vs 8.5%) with aspirin plus long-term _Brilinta_ compared to aspirin alone in patients
who had CAD and T2D without a history of heart attack or stroke.^(1) While this 
indication is not limited to this setting, the efficacy of _Brilinta_ was established
in a population with T2D in the THEMIS trial.^(2) The safety profile for _Brilinta_
was consistent with the known profile of the medicine with an increased risk of 
bleeding events observed.^(1)

The data from the THEMIS trial and the THEMIS-PCI sub-analysis were published in
The New England Journal of Medicine and The Lancet respectively.

Regulatory submissions to expand the approved indication for _Brilinta_ based on
the THEMIS trial are also under regulatory review in the EU, Japan and China.

AstraZeneca also recently announced the high-level results from the Phase III THALES
trial that showed aspirin plus _Brilinta_ 90mg reduced the risk of the composite
of stroke and death at 30 days after an acute ischaemic stroke or transient ischaemic
attack, compared to aspirin alone.

_Brilinta _is approved in more than 110 countries for the prevention of atherothrombotic
events in adult patients with acute coronary syndrome (ACS), and in more than 70
countries for the secondary prevention of CV events among high-risk patients who
have experienced a prior myocardial infarction.

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