aBLA Filing Intelligence & Biosimilar Opportunity

Leqembi

Lecanemab-Irmb

Antialzheimer

Injection

Leqembi is a prescription medicine for early-stage Alzheimer’s disease. It’s a monoclonal antibody that helps reduce amyloid plaques in the brain and is the first treatment of its kind approved in the European Union.

Approval Date

06-Jan-23

Data Exclusivity Expiry

06-Jan-27

Market Exclusivity Expiry

06-Jan-35

Commercial snapshot

Market performance & projections

Revenue ($M)

617

CAGR (%)

52.11%

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

1,223

2027

1,819

2028

2,579

2029

3,303

2030

3,941

2031

4,446

2032

4,919

Molecule profile

Details & specifications

Molecule

Lecanemab-Irmb

Innovator

EISAI INC.

Dosage Form

Injection

Strength

500 mg/5 mL (100 mg/mL), 200 mg/2 mL (100 mg/mL)

Therapeutic Category

Antialzheimer

Usage

To treat Alzheimer’s disease

Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

Why Spring Bio Solution

Supported 1000+ clinical trials globally

Provides services across regulatory, legal & clinical research

Unmatched intelligence on batches, expiry, spacing, and historical data from innovators

Integrated CRO services as part of our offerings

Insights on global pricing for smarter clinical trial supply decisions

Global sourcing capability across US, EU, South Africa, Canada, Japan, Australia, New Zealand, Southeast Asia, and other key markets

What is Leqembi and how does it work?

Who is eligible for Leqembi treatment?

How is Leqembi administered?

What are the potential side effects and monitoring requirements?

Leqembi is a monoclonal antibody treatment for early-stage Alzheimer’s disease. It works by targeting and reducing amyloid plaques in the brain, potentially helping to slow cognitive decline in patients with mild cognitive impairment or mild dementia.

Leqembi is for patients with early-stage Alzheimer’s disease, specifically mild cognitive impairment or mild dementia. Patients must have confirmed elevated beta-amyloid in the brain through testing like PET scans or spinal fluid analysis.

Leqembi is given as an IV infusion every two weeks at a healthcare facility. Each session requires medical supervision and regular monitoring by healthcare professionals.

The most common side effects of LEQEMBI include infusion-related reactions, ARIA, and headaches.