ITCH RELIEF

Name: Nemluvio HCP
Creator: Nemluvio

NEMLUVIO delivers fast and lasting itch relief for patients with PN¹

Itch relief as soon as

48

hours

(P≤0.005)¹*

49% of patients achieved significant itch relief^† at Week 16 vs 16% with placebo (P<0.0001)^2,3‡

Actor portrayal.

PP-NRS response defined as a ≥4-point improvement from baseline. Data from Phase 3 clinical study (OLYMPIA 2) post hoc descriptive analysis of daily PP-NRS improvement. Significant improvement was achieved at 48 hours (13% vs 3% with placebo).^1,2

More than 8 out of 10 patients saw itch relief with over a year of treatment¹

Graph image showing that 83% of NEMLUVIO® patients achieved continued itch improvement over 68 weeks.

Data from observed cases in OLYMPIA 2 treat-through population, interim analysis of the OLYMPIA LTE. No imputations for missing data. In the full population, 86% of patients (n=152) achieved PP-NRS improvement at Week 52. The OLYMPIA LTE is an ongoing prospective, multicenter, single-arm, open-label study up to 184 weeks.^1,4

REVIEW STUDY DESIGN

Assessments & Scales

Peak PRURITUS Numerical Rating Scale (PP-NRS)⁵

Patient-reported outcome designed to measure the worst itch over the previous 24-hour period
Treatment success defined as at least a 4-point improvement from baseline

68%

of patients taking NEMLUVIO were itch‑free or nearly itch‑free with over a year of treatment¹

Itch-free or nearly itch-free defined as PP-NRS <2⁵

Data from observed cases in the OLYMPIA 2 treat‑through population, Week 52 interim analysis of the OLYMPIA LTE. In the full population, 66% of patients (n=163) achieved PP‑NRS <2 at Week 52.^1,4

Lasting Skin Healing¹

Discover how NEMLUVIO healed most PN nodules for patients with PN¹

SEE THE DIFFERENCE

Favorable Safety Profile²

NEMLUVIO offers a favorable safety profile and requires no preliminary lab evaluations or ongoing lab monitoring²

REVIEW SAFETY PROFILE

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PP-NRS response defined as a ≥4-point improvement from baseline.²

Data shown from OLYMPIA 2; in OLYMPIA 1, 56% of patients achieved significant itch relief vs 16% for placebo.²

LTE=long-term extension; PN=prurigo nodularis; PP-NRS=Peak Pruritus Numerical Rating Scale.

References: 1. Galderma Laboratories, L.P.; data on file. 2. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P. 3. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.203065 [OLYMPIA 2]; September 2023. 4. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SIR.202699 [OLYMPIA LTE]; October 2023. 5. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389(17):1579-1589. doi:10.1056/NEJMoa2301333

IMPORTANT SAFETY INFORMATION

INDICATIONS: NEMLUVIO^® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for:

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.
the treatment of adults with prurigo nodularis.

CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.

WARNINGS AND PRECAUTIONS:
Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO.

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥1%) are:

Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia.
Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular.

USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women. The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug- associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus.

Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis.

Please see full Prescribing Information, including Patient Information.