Clinical Scorecard: FDA approves asundexian to reduce recurrent stroke risk

At a Glance

Key Highlights

• FDA approved asundexian 50 mg orally once daily in combination with antiplatelet therapy.
• In OCEANIC-STROKE, ischemic stroke occurred in 6.2% of asundexian recipients and 8.4% of placebo recipients, representing a 26% relative risk reduction.
• Major bleeding rates were similar overall: 1.6 versus 1.5 events per 100 person-years.
• Major bleeding rates were higher with asundexian among patients older than 75 years and during the first 90 days of treatment; gastrointestinal bleeding was also more frequent.
• The FDA prescribing information does not recommend routine coagulation monitoring and lists no contraindications.

Guideline-Based Recommendations

Diagnosis

• The FDA-approved population includes adults with a recent noncardioembolic ischemic stroke and NIH Stroke Scale score of 15 or lower, or a high-risk TIA.
• The indication does not extend to stroke prevention in patients with atrial fibrillation.

Management

• The FDA prescribing information specifies asundexian 50 mg once daily in combination with antiplatelet therapy.
• Withhold treatment for at least 24 hours before elective procedures and resume once adequate hemostasis is established.
• Withhold treatment for at least 24 hours after thrombolysis for acute ischemic stroke.
• Avoid concomitant use with combined P-glycoprotein and strong CYP3A4 inducers, including carbamazepine.
• Use is not recommended in patients with moderate or severe hepatic impairment.

Monitoring & Follow-up

• The FDA prescribing information does not recommend routine coagulation monitoring.
• Hepatic enzyme elevations were reported more frequently with asundexian.

Risks

• Major bleeding was higher with asundexian among patients older than 75 years (2.6 vs 1.7 events per 100 person-years) and during the first 90 days (4.5 vs 3.1 events per 100 person-years).
• Gastrointestinal bleeding occurred at 2.7 versus 2.1 events per 100 person-years.
• Diarrhea occurred in 3.4% of asundexian recipients versus 2.8% of placebo recipients.
• Concomitant combined P-glycoprotein and strong CYP3A4 inducers may reduce efficacy.

Patient & Prescribing Data

Adults with a recent noncardioembolic ischemic stroke (NIH Stroke Scale score 15 or lower) or high-risk TIA; not indicated for stroke prevention in atrial fibrillation.

The approved dose is 50 mg orally once daily with antiplatelet therapy. In OCEANIC-STROKE, participants were assigned within 72 hours of symptom onset, and median treatment duration was 14.2 months.

Clinical Best Practices

• The FDA prescribing information specifies use within the approved population and in combination with antiplatelet therapy.
• Follow the FDA prescribing information for withholding treatment before elective procedures and after thrombolysis.
• Follow the FDA prescribing information regarding interacting inducers and use in moderate or severe hepatic impairment.

Related Resources & Content

• FDA
• FDA Prescribing Information