Nemluvio
Immunology· 1978 cited findings· 2 source documents
Company: Galderma
What the regulatory reviews say
Nemluvio is approved for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. The recommended initial dosage for atopic dermatitis is 60 mg, followed by a maintenance dose of 30 mg every 8 weeks. For prurigo nodularis, the recommended dosage is an initial dose of 60 mg, followed by 30 mg every 4 weeks for patients weighing less than 90 kg, and 60 mg every 4 weeks for patients weighing 90 kg or more.
In clinical trials, Nemluvio demonstrated an IGA success proportion of 35.6% and an EASI-75 proportion of 43.5%. The overall incidence of treatment-emergent anti-drug antibodies (ADA) was 11.2%, with a persistent ADA incidence of 6.6%. The overall incidence of treatment-emergent neutralizing antibodies (NAb) was 0.5%. The drug received marketing authorization for prurigo nodularis on March 26, 2024.
Key figures — cited to the source page
| IGA success (proportion) | 35.6 | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.109 |
| EASI-75 (proportion) | 43.5 | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.109 |
| Overall incidence of treatment-emergent ADA | 11.2 | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.53 |
| Overall incidence of treatment-emergent NAb | 0.5 | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.53 |
| Persistent ADA incidence | 6.6 | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.53 |
| Approved indication | treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.18 |
| Recommended dosage for Atopic Dermatitis (initial) | 60 mg | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.18 |
| Marketing authorisation date for prurigo nodularis | 26 Mar 2024 | Galderma — Nemluvio EMA EPAR public assessment report (EMEA/, p.18 |
Source documents
Explore the full evidence
All 1978 cited findings for Nemluvio — searchable, comparable and answerable in plain language — are in the Immunology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.