---
title: "Weekly Recap: LEQEMBI IQLIK FDA approval and lecanemab SC bioequivalence"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/293259150.md"
description: "Eisai received FDA approval for LEQEMBI IQLIK, enabling flexible IV or subcutaneous dosing with at-home use. Data confirms the SC autoinjector is bioequivalent to IV administration. Interim LEADER safety data showed mostly mild ARIA (12.3%), while E2814 trials reported significant reductions in tau biomarkers."
datetime: "2026-07-20T22:14:20.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/293259150.md)
  - [en](https://longbridge.com/en/news/293259150.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/293259150.md)
generator: "portal-rs"
---

# Weekly Recap: LEQEMBI IQLIK FDA approval and lecanemab SC bioequivalence

Eisai (TSE:4523) won FDA approval for LEQEMBI IQLIK—flexible IV or subcutaneous dosing with at‑home use—and data show its SC autoinjector matches IV exposure and effects; interim LEADER safety found mostly mild ARIA, while E2814 trials report rapid, large tau biomarker reductions.

**Previous Week Recap**

-   **Eisai FDA Approves LEQEMBI IQLIK**: Eisai (4523) reported FDA approval of LEQEMBI IQLIK for early Alzheimer’s: flexible IV or subcutaneous dosing, switchable routes, and at-home administration from initiation through maintenance. 1 2
-   **Lecanemab SC Autoinjector Bioequivalent**: Eisai (4523): lecanemab SC autoinjector 500 mg weekly showed bioequivalent exposure to IV start (104%, 90% CI 99.1–109%). Similar amyloid reduction, clinical outcomes, ARIA‑E rates, 1.4% ADA. 3
-   **LEADER Update: ARIA Incidence**: Eisai (4523): LEADER interim safety update shows ARIA in 12.3% overall (ARIA-E 6.3%, ARIA-H 7.9%), mostly mild/asymptomatic; ARIA-E incidence differed by APOE ε4 status; no new large hemorrhages. 4
-   **AAIC 2026: E2814 Tau Reductions**: Eisai (4523): at AAIC 2026, E2814 cut plasma eMTBR‑tau243 ~78% at 3 months and >90% at 9 months; CSF eMTBR‑tau243 down 62% at 3 months, 89% at 9 months; CSF p‑tau and total tau also fell. 5

**Disclaimer**

This is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original sources.

### Related Stocks

- [4523.JP](https://longbridge.com/en/quote/4523.JP.md)

## Related News & Research

- [How Investors May Respond To Eisai (TSE:4523) Advancing Lecanemab Data And New CNS Oncology Filings](https://longbridge.com/en/news/292407767.md)
- [Eisai: Strong revenue and profit growth driven by key products and new market launches](https://longbridge.com/en/news/294650708.md)
- [SalMar – Record-strong biological performance](https://longbridge.com/en/news/296859687.md)
- [Revive Therapeutics Outlines Strategy to Build a Biodefence and Pandemic Preparedness Therapeutics Portfolio | RVVTF Stock News](https://longbridge.com/en/news/296357987.md)
- [BioArctic says Leqembi subcutaneous autoinjector shows efficacy, safety comparable to IV dosing in early Alzheimer’s disease](https://longbridge.com/en/news/292406011.md)

---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**