aBLA Filing Intelligence & Biosimilar Opportunity

Niktimvo

Axatilimab-Csfr

Immunomodulators

Intravenous Infusion

Niktimvo is an IV antibody treatment for adults and children (≥ 40 kg) with chronic graft‑versus‑host disease whose condition worsened despite at least two prior therapies. It works by blocking CSF‑1R to calm overactive immune cells and reduce symptoms.

Approval Date

14-Aug-24

Data Exclusivity Expiry

14-Aug-28

Market Exclusivity Expiry

14-Aug-36

Commercial snapshot

Market performance & projections

Revenue ($M)

152

CAGR (%)

0.5672

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

458

2027

647

2028

789

2029

917

2030

1055

2031

1143

2032

1236

Molecule profile

Details & specifications

Molecule

Axatilimab-Csfr

Innovator

INCYTE CORPORATION

Dosage Form

Intravenous Infusion

Strength

50 mg/mL, 9 mg/0.18 mL and 22 mg/0.44 mL

Therapeutic Category

Immunomodulators

Usage

To treat chronic graft-versus-host disease (cGVHD)

Good to know

Frequently asked questions

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