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FDA Medication Tracker

← All approvals · Immune & inflammatory · 2024

Nemluvio (nemolizumab-ilto)

The FDA approved Nemluvio (nemolizumab-ilto) on August 12, 2024 to treat prurigo nodularis.
Brand name
Nemluvio
Generic name
nemolizumab-ilto
FDA approval date
August 12, 2024
Approved use (FDA wording)
To treat prurigo nodularis
Company
Galderma Labs Lp
Application
BLA761390
Dosage form / route
INJECTABLE · INJECTION
Drug class (EPC)
Interleukin-31 Receptor alpha Antagonist [EPC]
Boxed warning on label
Not listed
Category on this site
Immune & inflammatory

Indications and usage, from the FDA label

NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. ( 1.2 ) 1.1 Prurigo Nodularis NEMLUVIO is indicated for the treatment of adults with prurigo nodularis. 1.2 Atopic Dermatitis NEMLUVIO is indicated for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in c…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.