BRILINTA FDA approval: A major step in reducing stroke risks in acute ischemic stroke and high-risk TIA patients

AstraZeneca has secured U.S. Food and Drug Administration (FDA) approval for BRILINTA (ticagrelor), expanding its use to reduce the risk of stroke in patients suffering from acute ischemic stroke or high-risk transient ischemic attack (TIA). This approval marks a significant milestone, building on the success of the THALES Phase 3 clinical trial, where BRILINTA, when combined with aspirin, demonstrated a substantial reduction in the occurrence of strokes and death.

A Landmark Moment for Stroke Prevention Treatment

The FDA’s decision to approve BRILINTA follows promising clinical trial results that show the combination of BRILINTA and aspirin can significantly lower the risk of stroke and death compared to aspirin alone. The THALES trial, which evaluated the treatment’s efficacy, demonstrated that BRILINTA 90 mg, when taken twice daily along with daily aspirin for 30 days, resulted in a 17% reduction in the primary composite endpoint of stroke and death in patients suffering from acute ischemic stroke or TIA.

This approval comes after the priority review designation granted by the FDA in July 2020, highlighting the urgency and potential impact of the treatment in this high-risk patient group.

Expert Insights on the Approval and Its Implications

Dr. Clay Johnston, the lead investigator of the THALES Phase 3 trial and Dean of the Dell Medical School at the University of Texas in Austin, emphasized the critical nature of this approval for both physicians and patients. “One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days,” Dr. Johnston said. “The approval of BRILINTA in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news for physicians and patients.”

The THALES trial’s success offers hope for stroke patients and healthcare providers alike, as recurrent strokes are a major concern for individuals who have already experienced an ischemic event. The approval of BRILINTA as an adjunct to aspirin represents a much-needed therapeutic option for these high-risk patients.

AstraZeneca’s Expanded Vision for BRILINTA

Mene Pangalos, AstraZeneca’s Executive Vice President of BioPharmaceuticals R&D, stressed the widespread impact of stroke in the U.S., noting, “In the US, someone has a stroke every 40 seconds, and the impact on a person’s life can be truly devastating.” With this new approval, AstraZeneca aims to broaden the treatment landscape for acute ischemic stroke and TIA patients, leveraging the proven efficacy of BRILINTA in patients with coronary artery disease (CAD). BRILINTA has already been widely recognized for its effectiveness in acute coronary syndrome (ACS) and secondary cardiovascular event prevention in more than 110 countries globally.

The Path Forward: Global Expansion and Further Approvals

AstraZeneca is not stopping with the FDA approval. The company has submitted regulatory applications to extend the approved indication for ticagrelor in China and the European Union, where it is branded as Brilique. These efforts aim to provide stroke and TIA patients worldwide with the benefits of this groundbreaking treatment.

Additionally, in May 2020, the FDA approved a new indication for BRILINTA, allowing its use in reducing the risk of a first heart attack or stroke in patients with high-risk coronary artery disease (CAD). This underscores BRILINTA’s growing role in managing both cardiovascular and cerebrovascular risks, reflecting AstraZeneca’s strategy of leveraging its established medications for expanded therapeutic uses.

BRILINTA’s Proven Track Record in Stroke and Cardiovascular Care

With more than 70 countries approving BRILINTA for secondary prevention of cardiovascular events, AstraZeneca’s innovative use of ticagrelor shows great promise. This new approval in acute ischemic stroke and TIA patients further reinforces the drug’s versatility and potential to significantly improve patient outcomes across a range of cardiovascular conditions.

In conclusion, BRILINTA’s approval for stroke prevention marks a pivotal step forward in the fight against recurrent strokes. With its dual mechanism of action and proven effectiveness, the drug is set to become an essential tool in stroke management, offering new hope to patients at high risk of further cerebrovascular events.