NEMLUVIO CLINICAL STUDY RESULTS IN PRURIGO NODULARIS

Shown to deliver healing you can see and feel

Not an actual patient.

NEMLUVIO quickly relieves the urge to scratch

AS SOON AS

48

hours1*

 

About half of adults using NEMLUVIO® had significant itch relief† by Week 16 (49% vs 16% with placebo)2

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; consistent results seen in OLYMPIA 1. Significant improvement was achieved at 48 hours (15% vs 3% with placebo, P≤0.005).1,2

Significant itch relief was defined as an itch improvement of at least 4 points on the PP-NRS, where 0 was no itch and 10 was worst itch imaginable.2

Lasting relief with NEMLUVIO

significant itch relief

8

OUT OF

10

adults achieved and maintained significant itch relief over 1 year of treatment1

itch-free or nearly 
ITCH-FREE

7

OUT OF

10

adults were itch-free or nearly itch-free‡ over 1 year of treatment1

Itch-free or nearly itch-free was defined as less than 2 on the PP-NRS.3

Clears nodules and heals the skin

More than one-third of adults using NEMLUVIO in clinical trials achieved clear or almost clear skin§ at Week 16 (38% vs 11% with placebo)2

BEFORE TREATMENT

Image of an actual 31-year-old female patient with raised bumps and nodules before NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).
Image of an actual 31-year-old female patient with raised bumps and nodules before NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).

AFTER TREATMENT

Image of an actual 31-year-old female patient with reduced raised bumps and nodules after NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).
Image of an actual 31-year-old female patient with reduced raised bumps and nodules after NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).

31-YEAR-OLD FEMALE.
Actual patient from clinical trial.
Photo altered to remove identifying marks.

AFTER 1 YEAR WITH TREATMENT

75%+

CLEARER SKIN

Most adults in the clinical trials had the majority of PN nodules healed after 1 year1

31-YEAR-OLD FEMALE. Actual patient from clinical trial. Photo altered to remove identifying marks. Individual results may vary. 

Clear or almost clear skin was defined as a 1 or below on the IGA scale, where 0 was clear and 4 was severe, with a 2-point or more improvement from baseline.2

The most common side effects of NEMLUVIO include: headache, skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches).2

 

Before and after 16 weeks with NEMLUVIO

All images are actual patients from clinical trial.

Image of an actual 43-year-old female patient with raised bumps and nodules before NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN). Image of an actual 43-year-old female patient with raised bumps and nodules before NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).
Image of an actual 43-year-old female patient with reduced raised bumps and nodules after NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN). Image of an actual 43-year-old female patient with reduced raised bumps and nodules after NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).
 

BEFORE TREATMENT

AFTER TREATMENT

43-YEAR-OLD 
FEMALE.
Actual patient from
clinical trial.

43-YEAR-OLD FEMALE.
Individual results may vary.

Image of an actual 73-­year-­old male patient with raised bumps and nodules before NEMLUVIO® (nemolizumab-­ilto) treatment for prurigo nodularis (PN). Image of an actual 73-year-old male patient with raised bumps and nodules before NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).
Image of an actual 73­-year­-old male patient with reduced raised bumps and nodules after NEMLUVIO® (nemolizumab­-ilto) treatment for prurigo nodularis (PN). Image of an actual 73-year-old male patient with reduced raised bumps and nodules after NEMLUVIO® (nemolizumab-ilto) treatment for prurigo nodularis (PN).
 

BEFORE TREATMENT

AFTER TREATMENT

73-YEAR-OLD 
MALE.
Actual patient from
clinical trial.

73-YEAR-OLD MALE.
Individual results may vary.

Individual results may vary.

43-year-old female.

73-year-old male.

Previous

Next

40%+
IMPROVEMENT
IN SLEEP
IMPROVEMENT
IN SLEEP

Proven to significantly improve sleep for adults with PN

More than half of adults using NEMLUVIO experienced a sleep improvement of at least 4 points on the SD-NRS by Week 16 (52% vs 21% with placebo). On the SD-NRS, 0 was no sleep loss and 10 was no sleep at all.1

NEMLUVIO was studied in the largest clinical 
trial of PN to date4

Over 550 adult participants with moderate-to-severe PN2

Studies evaluated measurements of itch, skin clearance, and effect on sleep, among other factors2

LEARN ABOUT NEMLUVIO SAFETY

NEMLUVIO was evaluated in 2 Phase 3 clinical trials and a long-term study. Results shown are from the second clinical trial|| and the long-term study.1

This clinical trial was called OLYMPIA 2.2

IGA=Investigator's Global Assessment; PN=prurigo nodularis; PP-NRS=Peak Pruritus Numerical Rating Scale; SD-NRS=Sleep Disturbance 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. 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 4. Galderma phase Ill data published in The New England Journal of Medicine: full Olympia 2 trial results demonstrate nemolizumab's rapid onset of action in patients with prurigo nodularis. Galderma Laboratories, L.P. Press release. Published October 26, 2023. Accessed November 15, 2024. https://www.galderma.com/news/galderma-phase-iii-data-published-new-england-journal-medicine-full-olympia-2-trial-results

Important Safety Information

Indications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used:

  • to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
  • to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

  • are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO.
  • are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

  • Breathing problems or wheezing
  • Swelling of the face, lips, mouth, tongue, or throat
  • Fainting, dizziness, feeling lightheaded
  • Fast pulse
  • Swollen lymph nodes
  • Joint pain
  • Fever
  • Skin rash (red or rough skin)
  • Nausea or vomiting
  • General ill feeling
  • Cramps in your stomach area

The most common side effects of NEMLUVIO include:

  • Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches
  • Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.