ITCH RELIEF

NEMLUVIO delivered fast and lasting itch relief in the ARCADIA clinical trials1

Itch relief as soon as

48

hours

(P≤0.001)1*

Consistent results were seen 
in ARCADIA 1 and ARCADIA 21

PP-NRS response defined as a ≥4-point improvement from baseline. Data from Phase 3 clinical study (ARCADIA 1) post hoc descriptive analysis of daily PP-NRS improvement. Significant improvement was achieved at 48 hours (9% with NEMLUVIO® + TCS/TCI vs 3% with placebo + TCS/TCI).1,2

Actor portrayal.

PP-NRS response defined as a ≥4-point improvement from baseline. Data from Phase 3 clinical study (ARCADIA 1) post-hoc descriptive analysis of daily PP-NRS improvement. Significant improvement was achieved at 48 hours (9% with NEMLUVIO® + TCS/TCI vs 3% with placebo + TCS/TCI).1,2

8 out of 10 patients taking NEMLUVIO experienced lasting itch relief with over a year of treatment1,3

Line graph showing 82% of NEMLUVIO® patients achieved continued itch improvement over 56 weeks for atopic dermatitis.
Line graph showing 82% of NEMLUVIO® patients achieved continued itch improvement over 56 weeks for atopic dermatitis.

Observed cases of ≥4-point improvement in the Pruritus VAS component of SCORAD in ARCADIA LTE interim analysis.1,3
At baseline, 925 patients had previously experienced NEMLUVIO, while 488 were in the NEMLUVIO-naïve group.1,3

REVIEW STUDY DESIGN 

Favorable Safety Profile2

NEMLUVIO was well tolerated, has no boxed warning, and requires no preliminary lab evaluations or ongoing lab monitoring2

REVIEW SAFETY PROFILE 

Q4W Dosing From the Start2

NEMLUVIO is the only biologic approved for AD with Q4W dosing from the start2,4

LEARN MORE 

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.