# AstraZeneca’s Brilinta granted FDA Priority Review for stroke

- Link: https://www.directorstalkinterviews.com/astrazenecas-brilinta-granted-fda-priority-review-for-stroke/412840424
- Published: 2020-07-09T07:29:39+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))
has announced the US Food and Drug Administration has accepted a supplemental New
Drug Application and granted Priority Review for _Brilinta_ for the reduction of
subsequent stroke in patients who experienced an acute ischemic stroke or transient
ischemic attack.

The Prescription Drug User Fee Act date, the FDA action date for this supplemental
application, is scheduled for the fourth quarter of 2020.

The sNDA was based on results from the Phase III THALES trial, which showed aspirin
plus _Brilinta_ 90mg used twice daily for 30 days resulted in a statistically significant
and clinically meaningful reduction in the risk of the primary composite endpoint
of stroke and death, compared to aspirin alone.^(1) The results were in line with
the known safety profile of _Brilinta_.^(1)

> **Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: **“Patients
> who have had an acute ischaemic stroke or transient ischemic attack are at high
> risk of experiencing a subsequent stroke, which may be disabling or fatal. Today’s
> Priority Review reflects _Brilinta_‘s potential as a much-needed treatment option
> to reduce the rate of subsequent stroke for these patients and we look forward
> to working with the FDA to make _Brilinta_ available as soon as possible.”

The data from the THALES trial will be published in a peer reviewed journal and 
presented at an forthcoming medical congress.

_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 cardiovascular events among high-risk 
patients who have experienced a heart attack. In May 2020, the FDA approved a label
update for _Brilinta_ in the US to include the reduction of the risk of a first 
heart attack or stroke in high-risk patients with coronary artery disease.

**Stroke**

Stroke is the second leading cause of death worldwide, with 6.2 million stroke-related
deaths in 2017, of which 2.7 million were due to ischaemic stroke.^(2) Patients 
who experience an acute ischaemic stroke or TIA are at high risk of developing subsequent
ischaemic events, with particularly high risk within 30 days after the initial event
and the highest risk period being the first 24 hours after the initial event.^(3)

**THALES**

THALES is an AstraZeneca sponsored, randomised, placebo-controlled, double-blinded,
international, multicentre, event-driven trial involving more than 11,000 patients
from 28 countries. It tested the hypothesis whether aspirin plus _Brilinta_ is superior
to aspirin alone in preventing the composite of stroke and death in patients with
non-cardioembolic acute ischaemic stroke or high-risk TIA. Patients were randomised
within 24 hours of onset of acute ischaemic stroke or high-risk TIA symptoms and
followed-up for 30 days of treatment. Trial treatments were _Brilinta_ 180mg loading
dose on day 1 as soon as possible after randomisation, followed by 90mg twice daily
on days 2-30, or matching placebo. All patients received open-label aspirin 300-
325mg on day 1, followed by 75-100mg once daily on days 2-30. The primary efficacy
outcome was the time to the composite endpoint of stroke and death at 30 days. The
primary safety outcome is time to first severe bleeding event according to the Global
Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary
Arteries (GUSTO) definition, which includes fatal bleedings, intracranial haemorrhage;
and bleeding causing hemodynamic compromise requiring intervention. Patients were
followed for an additional 30 days on standard of care.

**Brilinta**

_Brilinta_ (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist
that works by inhibiting platelet activation. _Brilinta_, together with aspirin,
has been shown to significantly reduce the risk of major adverse cardiovascular 
events (myocardial infarction, stroke or cardiovascular death), in patients with
ACS or a history of myocardial infarction (MI, heart attack).

_Brilinta_, co-administered with aspirin, is indicated for the prevention of atherothrombotic
events in adult patients with ACS, or for patients with a history of MI and a high
risk of developing an atherothrombotic event.

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