TRIAL RESULTS

NUCALA helped:

PREVENT exacerbations

NUCALA—the ONLY biologic to significantly reduce exacerbations in patients with a BEC ≥150 cells/µL*

18%

significant reduction

of moderate or severe exacerbations† at Week 52 for NUCALA + SOC,‡ 1.40/year (n=233) vs placebo + SOC,‡ 1.71/year (n=229). RR: 0.82 (P=0.04),§ METREX primary endpoint.1


Patients with BEC ≥150 cells/µL at screening

* At screening.

    

21%

significant reduction

in overall moderate or severe exacerbations† per year at Weeks 52-104 for NUCALA + SOC,‡ 0.80/year (n=403) vs placebo + SOC,‡ 1.01/year (n=401). RR: 0.79 (P=0.01),§ MATINEE primary endpoint.2

Patients with BEC ≥300 cells/µL at screening

  • †

    Moderate exacerbations defined as exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalization (≥24 hours) or resulting in death.3

  • ‡

    SOC=triple inhaled therapy (ICS + LABA + LAMA).

  • §

    Mean rate of exacerbations in previous year: MATINEE 2.3; METREX 2.5.1,2

MATINEE/METREX study designskeyboard_arrow_right

NUCALA helped:

REDUCE hospital visits due to exacerbations

NUCALA—the ONLY biologic studied for 2 years to help reduce HOSPITAL VISITS* due to exacerbations2

35%

reduction in exacerbations requiring hospitalization

and/or ED visit per year with NUCALA vs placebo

 

NUCALA, 0.13/year (n=403) vs placebo, 0.20/year (n=401) at

Weeks 52-104; RR: 0.65 (95% CI: 0.43, 0.96).2


MATINEE secondary endpoint; not statistically significant

due to failure earlier in the testing hierarchy.

* Hospitalizations/ED visits of any length.

MATINEE study designkeyboard_arrow_right

NUCALA exacerbation reduction data across subgroups

MATINEE post hoc analysis of exacerbations* by COPD subtypes†

After adding NUCALA to triple inhaled therapy:

31%

reduction of moderate or severe exacerbations* at
Weeks 52-104 in patients with
CHRONIC BRONCHITIS ONLY2,3

 

NUCALA 0.60 (n=170), Placebo 0.87 (n=168); RR: 0.69 (95% CI: 0.51, 0.93)

18%

reduction of moderate or severe exacerbations* at
Weeks 52-104 in patients with
EMPHYSEMA ONLY2,3

 

NUCALA 0.92 (n=120), Placebo 1.12 (n=132); RR: 0.82 (95% CI: 0.61, 1.12)

18% reduction in the subgroup with chronic bronchitis and emphysema (RR: 0.82; 95% CI: 0.53, 1.26).2,3‡

9% reduction in the subgroup without chronic bronchitis or emphysema known (RR: 0.91; 95% CI: 0.54, 1.54).2,3§

 

All results are descriptive.

  • *

    Moderate/severe exacerbations measured at Weeks 52-104.2

  • †

    COPD subtype assessed by the investigator. Subtype not known for all patients.

  • ‡

    Annualized rates: NUCALA (n=81) 0.88 vs placebo (n=62) 1.07.2,3

  • §

    Annualized rates: NUCALA (n=32) 0.84 vs placebo (n=37) 0.92.2,3

MATINEE study designkeyboard_arrow_right

BEC=blood eosinophil count; CI=confidence interval; ED=emergency department; ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; RR=rate ratio; SOC=standard of care.

NUCALA has a well-established safety profile based on 3 phase 3 trials

REVIEW SAFETY DATA

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

NUCALA is indicated for the: 

  • add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm.
  • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
  • add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients aged 18 years and older with inadequate response to nasal corticosteroids.
  • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Known hypersensitivity to mepolizumab or excipients.

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). Discontinue if a hypersensitivity reaction occurs.

 

Acute Symptoms of Asthma or COPD or Acute Deteriorating Disease

NUCALA should not be used to treat acute symptoms or acute exacerbations of asthma or COPD, or acute bronchospasm.

 

Opportunistic Infections: Herpes Zoster

Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

 

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

 

Parasitic (Helminth) Infection

Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

 

ADVERSE REACTIONS

Most common adverse reactions (≥5%):

  • Severe asthma trials: headache, injection site reaction, back pain, fatigue
  • CRSwNP trial: oropharyngeal pain, arthralgia
  • COPD trials: back pain, diarrhea, cough
  • EGPA and HES trials (300 mg of NUCALA): most common adverse reactions were similar to severe asthma

Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. Manifestations included rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reaction. A majority of systemic reactions were experienced the day of dosing.

 

USE IN SPECIFIC POPULATIONS

The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

 

Please see full Prescribing Information and Patient Information for NUCALA.

PMUS-MPLWCNT250056 June 2025

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Pavord ID, Chanez P, Criner GJ, et al. Mepolizumab for eosinophilic chronic obstructive pulmonary disease. N Engl J Med. 2017;377(17):1613-1629.

  2. Sciurba FC, Criner GJ, Christenson SA, et al. Mepolizumab to prevent exacerbations in COPD with an eosinophilic phenotype. N Engl J Med. 2025;392(17):1710-1720.

  3. Data on file, GSK.