Clinical Study Results

Improved bronchodilation with twice-daily UTIBRON NEOHALER

for people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

Improvement in lung function proven in 2 trials with UTIBRON NEOHALER1

>230 mL improvement in FEV1 AUC0-12hr vs placebo in two pivotal trails at Week 121,3

Chart showing UTIBRON NEOHALER made significant improvement in lung function

Chart showing UTIBRON NEOHALER made significant improvement in lung function

 

  • With the limited data available, there was no suggestion of a difference in FEV1 AUC0-12h with respect to age, sex, degree of airflow limitation, GOLD stage, smoking status, or inhaled corticosteroid use.

All LABAs including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; UTIBRON NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients.

 


 

Lung function improvement sustained over a 24-hour period with twice-daily dosing2,3

Change in FEV1 from baseline over a 24-hour period at Week 12 in Trial 12†

Chart showing FEV1 change over a 24 hour period at Week 12 in clinical trials

Chart showing FEV1 change over a 24 hour period at Week 12 in clinical trials

The efficacy and safety of UTIBRON NEOHALER were established in two 12-week, multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled trials of 2038 patients. The primary end point was change in FEV1 AUC 0-12hr at Week 12 from baseline vs placebo, glycopyrrolate, and indacaterol. Secondary end points included change in St. George’s Respiratory Questionnaire total score, rescue medication use, trough FEV1, and peak FEV1 vs placebo at Week 12.1-3 

AUC=area under the curve; FEV1=forced expiratory volume in 1 second.


Starts working in 5 minutes, and lasts all day and night with twice-daily dosing1,2

UTIBRON NEOHALER is not a rescue medication and does not replace fast-acting inhalers to treat acute symptoms.


Meaningful improvements in trough FEV1

>210 mL improvement vs placebo at Week 12 in 2 trials3

Chart showing trough FEV1 improvement with UTIBRON NEOHALER

  • Clinically important difference in trough FEV1 is defined as ≥100 mL improvement vs placebo3
  • Trough FEV1 is the mean of FEV1 at 23 hr 15 min and 23 hr 45 min after the morning dose3

UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

 


 

Meaningful improvements in peak FEV1

>260 mL improvement vs placebo at Week 12 in trials3

Chart showing peak FEV1 improvement with UTIBRON NEOHALER

  • The peak FEV1 was defined as the maximum FEV1 recorded within 4 hours after the morning dose on Days 1 and Week 121
  • UTIBRON NEOHALER demonstrated improvement from baseline in peak FEV1 vs placebo on Day 11
    • 185 mL in Trial 1
    • 151 mL in Trial 2

FEV1=forced expiratory volume in 1 second.

Reduced rescue medication use over 24 hours with twice-daily UTIBRON NEOHALER

Greater reduction in daily rescue medication use vs placebo in 2 trials2*

Graphic showing reduction in need for rescue medication with UTIBRON NEOHALER

Graphic showing reduction in need for rescue medication with UTIBRON NEOHALER

  • UTIBRON NEOHALER is not a rescue inhaler and is not indicated to treat episodes of acute bronchospasm1
  • The mean daily number of puffs of rescue medication at baseline was Trial 1: UTIBRON NEOHALER, 4.88; placebo, 4.87; and Trial 2: UTIBRON NEOHALER, 4.25; placebo, 4.71.

*The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with nonmissing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient.

UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

Clinically meaningful improvement in health-related quality of life as measured by SGRQ

Graphic showing Utibron improved quality of life 60%

Graphic showing Utibron improved quality of life 60%

  • Meaningful improvement is defined as a ≥4-point decrease in SGRQ total score2
  • Meaningful improvement in SGRQ score reported by 59% of patients taking UTIBRON NEOHALER vs 35% with placebo in Trial 1 (odds ratio of 2.9 [95% CI: 1.9, 4.2]) and 57% of patients taking UTIBRON NEOHALER vs 39% with placebo in Trial 2 (odds ratio of 2.2 [95% CI: 1.5, 3.2])1,2

St. George’s Respiratory Questionnaire (SGRQ) measures the impact of COPD on quality of life.

The SGRQ is a patient-reported measurement that evaluates 3 subcomponents that produce a total score: physical activity, social engagement, and symptom improvement. Improvement in SGRQ is based on the total score and not on the individual subcomponents.4

Immediate hypersensitivity reactions have been reported with UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.


References:
1. UTIBRON NEOHALER [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2017.
2. Data on file. FLIGHT2 and FLIGHT1 clinical study reports. Sunovion Pharmaceuticals Inc.
3. Mahler D, Kerwin E, Ayers T, et al. FLIGHT1 and FLIGHT2: efficacy and safety of QVA149 (indacaterol/glycopyrrolate) versus its monocomponents and placebo in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2015;192(9):1068-1079.
4. Jones P, Quirk F, Baveystock C. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.

Important Safety Information & Indication

Important Safety Information

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including indacaterol, one of the active ingredients in UTIBRON NEOHALER.

The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is not indicated for the treatment of asthma.



All LABAs, including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; UTIBRON NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients.

UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

UTIBRON NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using UTIBRON NEOHALER should not use another medicine containing a LABA for any reason.

Immediate hypersensitivity reactions have been reported with UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

As with other inhaled medicines, UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted.

Indacaterol, like other beta2-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.

As with other beta2-adrenergic agonists, indacaterol should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.

As with other beta2-adrenergic agonists, UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis (4.1% vs 1.8%), hypertension (2.0% vs 1.4%), back pain (1.8% vs 0.6%), and oropharyngeal pain (1.6% vs 1.2%).

UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see the full Prescribing Information, including BOXED WARNING and Medication Guide, for UTIBRON NEOHALER.


Indication

UTIBRON™ NEOHALER® (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important limitations: UTIBRON NEOHALER is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.