US EditionPublished • loading... • Updated
FDA grants priority review to weekly at-home Alzheimer's injections
The FDA's Priority Review targets Eisai's weekly subcutaneous LEQEMBI IQLIK, potentially enabling at-home treatment for early Alzheimer's and reducing healthcare resource use.
- Eisai Co., Ltd. and Biogen Inc. said the U.S. Food and Drug Administration has granted Priority Review for the LEQEMBI IQLIK sBLA, with a PDUFA date of May 24, 2026.
- Eisai and Biogen submitted the sBLA after trials showed once-weekly 500 mg SC exposure matches bi-weekly IV dosing and is supported by Phase 3 Clarity AD OLE sub-studies.
- Clinical outcomes noted symptomatic ARIA and recovery rates, with ARIA‑E observed at 13 and symptomatic ARIA in 3%, serious ARIA in 0.7%, and MRI resolution in 52% of ARIA‑E patients by 12 weeks.
- If approved, the autoinjector could administer a once-weekly starting dose via two injections, each 250 mg injection taking about 15 seconds, expanding U.S. maintenance approval .
- Prescribers should perform ApoE ε4 testing before starting treatment to assess ARIA risk, consider ARIA‑E before thrombolytics using MRI monitoring, and exercise caution with antithrombotic and anticoagulant therapies due to ICH risk.
Insights by Ground AI
24 Articles
24 Articles
Bennington Banner+20 Reposted by 20 other sources
FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease
Coverage Details
Total News Sources24
Leaning Left4Leaning Right0Center8Last UpdatedBias Distribution67% Center
Bias Distribution
- 67% of the sources are Center
67% Center
L 33%
C 67%
Factuality
To view factuality data please Upgrade to Premium
