Eisai and BioArctic Presented Results of Leqembi as Subcutaneous Dosage Form in P-III Trial for Alzheimer’s Disease CTAD 2023
Shots:
- The P-III (Clarity AD) clinical trial evaluates the safety & efficacy of Leqembi SC vs IV in patients (n=72 vs 322) with Alzheimer's Disease
- The results depicted a 14% greater reduction in amyloid plaque (-40.3 ± 2.27 vs -35.4 ± 1.14), 11% higher AUC, 90% CI for drug exposure & a consistent incidence of ARIA-E, ARIA-H & ARIA-H (16.7%, 22.2% & 8.3% vs 12.6%, 17.3% & 8.9%) when treated with SC vs IV dosage form
- Moreover, data from the tau PET longitudinal sub-study demonstrated that 76% of the patients showed no decline & 60% showed clinical improvement at 18mos. in low-tau / earlier stage early AD population. Additionally, based on these results the company expects to submit a BLA to the US FDA by Mar 31, 2024
Ref: PR Newswire | Image: EISAI
Related News:- Eisai and Biogen Report the Health Canada Acceptance of New Drug Submission for Leqembi (lecanemab) to Treat Early Alzheimer's Disease
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
