On this page

LECANEMAB AUTOINJECTOR

lecanemab-irmb · Injection, Solution

Prescription BLA

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

LECANEMAB AUTOINJECTOR

Generic name

lecanemab-irmb

Dosage form

Injection, Solution

Route

Subcutaneous

Marketing category

BLA · BLA

Labeler

Eisai Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

46% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Lecanemab-Irmb	200 mg/mL	2626147	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection, Solution

Route of administration

Subcutaneous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Amyloid Beta-directed Antibody Interactions [MoA]	MoA	2 members — no class page
Amyloid Beta-directed Antibody [EPC]	EPC	2 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

761375

Application type

BLA · Biologics License Application

Approval date

August 29, 2025

Sponsor

EISAI INC

Products on application

Submissions recorded

Products approved under application 761375.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
761375-003	LEQEMBI IQLIK	INJECTABLE		LECANEMAB-IRMB	Prescription	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 761375.
Type	No.	Action	Status	Date	Review
Supplement	1	Efficacy	Approved	July 13, 2026	Priority
Original application	1		Approved	August 29, 2025	Standard

Review documents

0 · Supplement · July 20, 2026
0 · Supplement · July 15, 2026
0 · Supplement · July 15, 2026
0 · Original application · September 3, 2025
0 · Original application · September 2, 2025

Adverse event reports

Source: openFDA FAERS

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LECANEMAB-IRMB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
62856-220-01	62856-220	Eisai Inc.	1 SYRINGE, PLASTIC in 1 CARTON (62856-220-01) / 1.8 mL in 1 SYRINGE, PLASTIC (62856-220-10)	August 29, 2025
62856-222-02	62856-222	Eisai Inc.	2 SYRINGE, PLASTIC in 1 CARTON (62856-222-02) / 1.25 mL in 1 SYRINGE, PLASTIC (62856-222-10)	July 13, 2026
62856-220	62856-220	Eisai Inc.	—	August 29, 2025
62856-222	62856-222	Eisai Inc.	—	July 13, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.