Sector News

US priority review for AZ’ Brilinta/aspirin combination

July 13, 2020
Life sciences

The US Food and Drug Administration has agreed to a speedy review of AstraZeneca’s Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who have experienced an acute ischaemic stroke or transient ischaemic attack (TIA).

The marketing application is based on data 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.

“Patients who have had an acute ischaemic stroke or transient ischaemic attack are at high risk of experiencing a subsequent stroke, which may be disabling or fatal. [The] 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,” commented Mene Pangalos, executive vice president, BioPharmaceuticals R&D, at AZ.

Specific data from the trial have not yet been shared, but are to be published in a peer reviewed journal and presented at an forthcoming medical congress, AZ noted.

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.

An approval in combination with aspirin to prevent a second stroke would significantly expand the drug’s reach.

By: Selina McKee

Source: Pharma Times

comments closed

Related News

September 25, 2022

Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences

Life sciences

Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence.

September 25, 2022

Mount Sinai AI uncovers new brain analysis method to predict dementia, Alzheimer’s disease

Life sciences

Current methods for diagnosing Alzheimer’s disease rely on a complex combination of self- and caregiver-reported symptoms, a physical examination and either a PET scan or a spinal tap to look for evidence of amyloid plaque build-ups in the brain. But a new artificial intelligence-based method may make the diagnostic process a much more objective one.

September 25, 2022

New AstraZeneca-backed report finds big money behind diverse owners and entrepreneurs in Europe

Life sciences

There is lots of talk about diversity and inclusion in business, including in pharma and medtech. A new report by the Open Political Economy Network (OPEN), a think tank focusing on migration and diversity, released its “Minority Businesses Matter: Europe” report highlighting the successes and challenges of ethnic minority-owned businesses in Europe.