Table of Contents
ATS 2020 Virtual is happening from August 5 to August 10, and it is exciting to watch major Respiratory Pharmaceutical companies and their key presentations.
GlaxoSmithKline’s Trelegy Ellipta for the treatment of Inadequately Controlled Asthma
GlaxoSmithKline is worth mentioning here, as it is presenting key posters and studies on Trelegy Ellipta in uncontrolled asthma patients.
Trelegy Ellipta History:
Trelegy Ellipta (fluticasone furoate /umeclidinium/vilanterol) is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day.
GSK is developing this therapy in collaboration with Innoviva, Inc., a company with a portfolio of royalties that include respiratory assets partnered with GSK including RELVAR/BREO ELLIPTA (fluticasone furoate/ vilanterol, “FF/VI”), ANORO ELLIPTA (umeclidinium bromide/ vilanterol, “UMEC/VI”) and TRELEGY ELLIPTA (the combination FF/UMEC/VI).
Innoviva is also entitled to 15% of royalty payments made by GSK under its agreements originally entered, and since assigned to Theravance Respiratory Company, LLC relating to TRELEGY ELLIPTA and any other product or combination of products that may be discovered and developed in the future under the LABA (long-acting beta2 agonist) Collaboration.
Trelegy Ellipta Facts:
- FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day.
- It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. By blocking TSLP, it prevents the release of pro-inflammatory cytokines resulting in the prevention of asthma exacerbations and improved asthma control.
- In October 2019, GSK filed a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for Trelegy Ellipta for the treatment of asthma in adults.
- In February 2020, GSK announced the acceptance of regulatory submission seeking an additional indication for the use of Trelegy Ellipta for the treatment of asthma in adults by the European Medicines Agency (EMA).
- It is expected that this single-inhaler triple therapy would introduce a new treatment paradigm for managing those adult patients who remain symptomatic on an ICS/LABA combination.
- If approved, this would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.
- GSK’s filing is supported by data from the phase III clinical study CAPTAIN, conducted in adults with uncontrolled asthma with positive results were reported in May 2019.
- The CAPTAIN study was designed to evaluate once-daily single inhaler triple therapy as a treatment for adults whose asthma is inadequately controlled despite treatment with maintenance asthma medication. The analyses being presented at ATS provide new insights on triple therapy and the movement towards personalized treatment.
- In September 2017, FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma.
- In November 2017, Trelegy Ellipta was approved in the European Union for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) who are not adequately treated by an ICS/LABA combination.
Title – Captain Study: Evaluating the Efficacy of Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI in Inadequately Controlled Asthma Using Change in Asthma Control Questionnaire and the Relationship with Trough FEV1
Conclusions: FF/UMEC/VI improved asthma control compared with FF/VI measured by both change from baseline in ACQ-7 score and responders across all ACQ measures. The improvement in ACQ-5/6 and the modest relationship observed between change in trough FEV1 and ACQ-7 response suggests that improved control is not only driven by changes in lung function.
Title – Captain Study: Daily Digital Spirometry and Symptom Data for Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Asthma
Conclusions: The addition of UMEC to FF/VI results in early and sustained improvements in daily measures of lung function and asthma symptoms, thus showing consistency of continuous home-based measures of spirometry and patient-reported symptoms. These alternatives to clinic-based measures demonstrate added benefit of FF/UMEC/VI in asthma patients uncontrolled on ICS/LABA and provide differentiating evidence for doubling doses of UMEC.
Title – Captain Study: Simultaneous Step-Up to High Dose Fluticasone Furoate and Addition of Umeclidinium for the Treatment of Inadequately Controlled Asthma
Conclusions: Increasing FF dose from 100 to 200 mcg/day or adding UMEC 62.5 mcg led to numerical improvements in all endpoints without additional safety signals. Simultaneously doubling FF dose and adding UMEC 62.5 mcg resulted in the greatest improvements in lung function and symptom control (ACQ-7), indicating that the treatment effects were additive. Increasing FF dose and adding UMEC in a single step represents a therapeutic option for patients with asthma that are inadequately controlled on FF/VI 100/25 mcg.
Title – Captain Study: Treatable Traits and the Outcome of Treatment with Inhaled Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI Therapies in Patients with Uncontrolled Asthma, a Pre-Specified Subgroup Analysis
Conclusions: The addition of UMEC improved trough FEV, independently of baseline blood eosinophil and FeNO levels. A precision medicine approach targeting treatment according to the desired outcome and type 2 biomarker status might lead to the more effective and economic use of inhaled treatments.
Regeneron and Sanofi’s SAR440340 (REGN3500) Improved Pre-BD FEV1 in Patients with Moderate to Severe Asthma
Regeneron and Sanofi Genzyme are worth mentioning here, as they are presenting key poster of their Phase II therapy REGN3500 in moderate-to-severe asthma patients.
Regeneron and Sanofi are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is thought to play an underlying role.
REGN3500 is being studied in Phase II trials for asthma, chronic obstructive pulmonary disease and atopic dermatitis. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.
- SAR440340 is a fully-human monoclonal antibody that inhibits interleukin-33 (IL-33), a protein that is believed to play a key role in type 1 and type 2 inflammation.
- Preclinical research showed SAR440340 blocked several markers of both types of inflammation. In moderate-to-severe asthma, there can be multiple sources of underlying inflammation that new therapies may help address.
- SAR440340 was invented using Regeneron’s proprietary VelocImmune technology that yields optimized fully-human antibodies, and is being developed jointly by Regeneron and Sanofi as part of a global collaboration agreement.
- Despite standard-of-care treatment with inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) therapy, people with moderate-to-severe asthma often have inadequately controlled, persistent symptoms that may make them suitable for treatment with a biologic therapy. These people live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations.
- In June 2019, Sanofi and Regeneron Pharmaceuticals announced Phase II proof-of-concept trial evaluating the SAR440340 met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also met a key secondary endpoint, demonstrating REGN3500 monotherapy significantly improved lung function compared to placebo.
- Detailed efficacy and adverse events data from a phase II proof of concept study in Asthma presented were presented at American Thoracic Society Conference (ATC-2020).
Title – SAR440340, An Anti-IL-33 Monoclonal Antibody, Demonstrated a Significant Reduction of LOAC Events and Improved Pre-BD FEV1 in Patients with Moderate to Severe Asthma: Results from the Phase II Proof of Concept Study.
Conclusions: SAR440340 significantly reduced the proportion of patients with LOAC events vs. placebo, improved pre-BD FEV1, and was generally well-tolerated in moderate-to-severe asthma patients after 12 weeks of treatment. Dupilumab effects on LOAC and pre-BD FEV1 were consistent with previous dupilumab studies. The effects on pre-BD FEV1 were greater for both therapies in patients with baseline blood eosinophils ≥300 cells/μl. Although the study was not powered for between-group comparisons, dupilumab effects were generally numerically higher than for SAR440340, and the combination did not demonstrate incremental improvements.
Analyst Views: “This trial suggests that REGN3500 may provide an alternative targeted approach for patients suffering from asthma. Asthma is a heterogeneous disease and not everyone experiences it in the same way. Therefore, there is value in evaluating new therapies with distinct and novel mechanisms such as anti-IL-33”.
AB Science’s Mastinib Decreases the Rate of Asthma Exacerbations in Patients with Severe Asthma
AB Science is worth mentioning here, as it is presenting key poster on its Phase III study severe asthma patients.
AB Science is majorly involved in the research, development and commercialization of protein kinase inhibitors (PKIs). AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, and inflammatory diseases.
- Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases.
- Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
- Data suggests that mast cells are involved in allergic and anaphylactic reactions, playing an important role in hypersensitivity and inflammatory processes of the disease and also tissue remodeling of the airways.
- Masitinib is currently investigated both in severe asthma uncontrolled by oral corticosteroids (OCS) and severe asthma uncontrolled by high dose inhaled corticosteroids (ICS).
- Asthma uncontrolled by oral corticosteroid is the most severe form of asthma and represents a high unmet medical need. Quality-of-life for such patients is severely affected, with major reduction in lung function, restrictions on activities of daily living, frequent asthma exacerbations and greater risk of life-threatening asthma exacerbations. Masitinib, by inhibiting mast cells activation is expected to show clinical benefits in patients with moderate to severe asthma and to be an alternative to ineffective corticosteroid therapy.
- In November 2019, company announced Phase III trial results, showing the Mastinib has met its primary end point in severe asthma uncontrolled by oral corticosteroids and further detailed results have been published in ATS2020.
Title – Masitinib Significantly Decreases the Rate of Asthma Exacerbations in Patients with Severe Asthma Uncontrolled by Oral Corticosteroids: A Phase 3 Multicenter Study
Conclusions: Masitinib, a first-in-class tyrosine kinase inhibitor targeting mast cell activity in severe asthma patients, demonstrated a positive benefit/risk ratio over a sustained period and may provide a new treatment option in severe asthma, irrespective of baseline eosinophil level.
Analyst Views: “This is the first positive large scale study in severe asthma utilizing a tyrosine kinase inhibitor, offering an alternative to monoclonal antibodies which are administered intravenously. It also supports the idea that mast cells are an important therapeutic target in severe asthma. The positive results suggests that masitinib could be a new oral treatment option in this difficult to treat population asthma population, including for severe eosinophilic asthma”
Regeneron and Sanofi’s Dupilumab (Dupixent) reduced severe exacerbations and improved lung function in patients with uncontrolled, moderate-to-severe Asthma with an eosinophilic phenotype across baseline IgE levels
Regeneron and Sanofi Genzyme are worth mentioning here, as they are presenting key posters and studies on Dupilumab in moderate-to-severe uncontrolled asthma patients.
In 2007, Sanofi and Regeneron partnered together to split U.S. profits and losses 50-50 and ex-U.S. proceeds on a sliding scale. Along the way, Regeneron has opted to co-promote Dupixent, now approved to treat severe eczema, asthma and nasal polyps; Praluent; and Kevzara in the U.S.
- Dupixent is a human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that play a central role in type 2 inflammation that underlies specific types of asthma as well as several other allergic diseases. This effect is associated with the reduction of type 2 inflammatory biomarkers including FeNO, immunoglobulin E (IgE) and eotaxin-3 (CCL26).
- Despite being compliant with their current medicine, many people with moderate-to-severe asthma, including those with eosinophilic phenotype or with oral steroid dependence, live with persistent symptoms like unpredictable attacks and difficulty breathing.
- Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy.
- Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients – those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma.
- In moderate-to-severe asthma Dupixent has been shown to provide rapid and sustained improvement in lung function, and a marked reduction in exacerbations. This efficacy is sustained out to almost three years. Furthermore, the safety profile was consistent with previously reported data.
- In October 2018, US FDA approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
- In May 2019, European Commission approved a new indication for Dupixent in asthma. Dupixent is now approved in the European Union (EU) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.
Title – Dupilumab Improved Pre-Bronchodilator FEV1 in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma, Regardless of Presence of Perennial Aeroallergen-Specific IgE: LIBERTY ASTHMA QUEST Study
Conclusions: Dupilumab significantly reduced severe exacerbations and improved lung function as measured by pre-bronchodilator FEV1 at Week 12 across all IgE subgroups in patients with uncontrolled, moderate-to-severe asthma with an eosinophilic phenotype.
Title – Dupilumab Reduced Oral Corticosteroid Use in Patients with OCS-Dependent Severe Asthma Consistently Across Baseline Disease Characteristics in the Phase III LIBERTY ASTHMA VENTURE Study
Conclusions: No significant treatment-by-subgroup interactions were identified. A consistent reduction in OCS dose with dupilumab vs placebo at Week 24 was observed in patients with OCS-dependent, severe asthma across all levels of baseline disease characteristics.
Title – Dupilumab Improves Asthma Control as Assessed by Total and Individual Item Scores of the 6-Item Asthma Control Questionnaire in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps and Comorbid Asthma: Pooled Results from the SINUS-24 and SINUS-52 Phase III Studies
Conclusions: Among patients with CRSwNP with comorbid asthma, dupilumab improved asthma control, including symptoms, night-time awakening, activity limitation, and use of rescue medications.
Title – Meta-Analyses of Dupilumab versus Standard of Care in Patients with Uncontrolled, Persistent Asthma
Conclusions: These meta-analyses demonstrated that dupilumab significantly reduced severe exacerbation rates in subgroups of patients with uncontrolled, persistent eosinophilic asthma. NNTs indicated that only one patient would need to be treated with dupilumab instead of SOC to have one less severe asthma exacerbation per year.
Title – Dupilumab Reduced Oral Corticosteroid (OCS) Use in Patients with OCS-Dependent, Severe Asthma Consistently across Baseline Demographic Characteristics in the Phase III LIBERTY ASTHMA VENTURE Study
Conclusions: No significant treatment-by-subgroup interactions were identified. A consistent reduction in OCS dose with dupilumab vs placebo at Week 24 was observed in patients with OCS-dependent, severe asthma across all levels of baseline demographic characteristics.
Chiesi Farmaceutici’s Fixed Triple Dose Combination of Extra Fine Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide (BDP/FF/G) in Asthma Patients
Chiesi Farmaceutici is worth mentioning here, as it is presenting key posters and studies on various therapies in moderate-to-severe asthma patients.
- A singleinhaler triple therapy consisting of an extra-fine formulation (ie, with mass median aerodynamic diameter <2 μm) of the inhaled corticosteroid beclometasone dipropionate (ICS), the longacting β2 agonist (LABA) formoterol fumarate, and the longacting muscarinic antagonist (LAMA) glycopyrronium delivered via a pressurized metereddose inhaler is in development for patients with asthma. Such extra-fine formulations result in an improved deposition in the small airways, which is potentially important given that patients with asthma with substantial dysfunction of the small airways tend to have worse asthma control and quality of life and are at increased exacerbation risk.
- The drug is available for patients with COPD.
- The real role of single inhaler triple therapy in asthma will be demonstrated when the various trials that are currently ongoing or are scheduled will be completed. It is appropriate to treat with triple therapy asthmatic patients who have smoked and remain symptomatic or suffer from frequent exacerbations despite initial inhaler therapy with ICS/LABA.
- Data was assessed from two randomized, double-blind, parallel-group, active-controlled studies (TRIMARAN and TRIGGER) on the efficacy and safety of single-inhaler triple therapy in adult patients with uncontrolled asthma.
- Rate of severe asthma exacerbations was reduced by 23% (p=0.0076) over 52 weeks of treatment with BDP/FF/G vs BDP/FF.
Title – Effect of High ICS Dose Fixed Combination Extra Fine Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide (BDP/FF/GB) on Lung Function in Asthmatics with Persistent Airflow Limitation (PAL): A Post-Hoc Analysis of the TRIGGER Study
Conclusions: In patients with asthma uncontrolled on high ICS dose ICS/LABA, triple therapy with high ICS dose extra-fine BDP/FF/GB significantly improves lung function vs BDP/FF. Consistent with data from other studies, a more pronounced bronchodilator effect is seen in the subset of patients with PAL.
Title – Effect of Medium ICS Dose Fixed Combination Extra Fine Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide (BDP/FF/GB) pMDI on Lung Function in Asthmatics with Persistent Airflow Limitation (PAL): A Post-Hoc Analysis of the Trimaran Study
Conclusions: In patients with asthma uncontrolled on medium ICS dose ICS/LABA, extra fine triple therapy with medium ICS dose BDP/FF/GB significantly improves lung function vs BDP/FF. Consistent with data from other studies, a more pronounced bronchodilator effect is seen in the subset of patients with PAL.
Analyst Views: “Some patients with uncontrolled asthma are required to use two different inhalers, of different design and with different instructions for use – and often with different dosing regimens. This is not only inconvenient for patients and healthcare providers who provide instruction on correct inhaler use but can negatively impact treatment adherence and persistence, leading to poor disease control. These findings are exciting for patients and healthcare providers alike because they provide first time evidence of the benefits of a single-inhaler triple combination of BDP/FF/G for those with uncontrolled asthma.”
Novartis’ Combination of Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate (IND/GLY/MF) (QVM149) (Enerzair Breezhaler) for the Treatment of Patients with Uncontrolled Asthma
Novartis is worth mentioning here, as it is presenting key posters and studies on IND/GLY/MF in uncontrolled asthma patients.
In April 2005, Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis by Sosei Heptares and Vectura. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc., for use in QVM149 (Worldwide excluding US). Novartis is responsible for the development and commercialization of QVM149.
- This formulation combines the comprehensive bronchodilation, rendered by indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonist]), with the anti-inflammatory action of mometasone furoate (high- or medium-dose ICS [inhaled corticosteroid]) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler device.
- Results have shown that the investigational, once-daily, inhaled QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate or IND/GLY/MF) is superior to QMF149 (indacaterol acetate and mometasone furoate or IND/MF) in improving trough forced expiratory volume in one second (FEV1) after 26 weeks, meeting the primary endpoint of the Phase III IRIDIUM clinical trial.
- Despite being on treatment with LABA/ICS, nearly half of all patients with moderate-to-severe asthma are uncontrolled and at a higher risk of exacerbations, hospitalization, or even death. For these patients, it is important to explore additional options in the asthma market to improve treatment outcomes and quality of life. The initial results of IRIDIUM showed that QVM149 can improve lung function in these patients and potentially deliver a substantial reduction in exacerbation rates, which can have a significant impact on the daily lives of people with uncontrolled asthma.
- In July 2020, the European Commission approved Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide, and mometasone furoate) for uncontrolled asthma. The drug has been cleared as a maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.
- In June 2020, the Japanese Ministry of Health, Labour, and Welfare approved Enerzair Breezhaler glycopyrronium / indacaterol/ mometasone furoate for the treatment of asthma in Japan.
Title – Medium-Dose Indacaterol/Glycopyrronium/Mometasone Furoate Fixed-Dose Combination Improves Lung Function Compared with High-Dose Indacaterol/Mometasone Furoate and Salmeterol/Fluticasone and Reduces Exacerbation Rates versus High-Dose Salmeterol/Fluticasone in Moderate-to-Severe Asthma: The IRIDIUM Study
Conclusions: IND/GLY/MF medium-dose q.d. resulted in a significant improvement of lung function and a reduction in moderate/severe and all exacerbations versus SFC high-dose b.i.d., while reducing the steroid load. IND/GLY/MF medium-dose q.d. also improved lung function versus high-dose IND/MF q.d. in patients with uncontrolled asthma.
Title – Indacaterol/Glycopyrronium/Mometasone Furoate Improves Lung Function and Reduces Exacerbations Versus Long-Acting β2-Agonist/Inhaled Corticosteroid Standard-of-Care in Patients with Uncontrolled Asthma: The Phase III IRIDIUM Study
Conclusions: The combination inhaled therapy of IND/GLY/MF medium-dose and high-dose q.d. significantly improved lung function versus the comparators, demonstrated comparable improvements in asthma control from baseline versus the respective IND/MF q.d. doses and SFC high-dose b.i.d., and reduced asthma exacerbations versus this standard-of-care in patients with uncontrolled asthma.
Title – Non-Inferior Improvement in Asthma Quality of Life and Favorable Benefit in Terms of Lung Function and Asthma Control with Inhaled Combination of Indacaterol/Glycopyrronium/Mometasone Furoate Once-Daily Compared with the “Loose” Combination of Salmeterol/Fluticasone Twice-Daily Plus Tiotropium in Patients with Uncontrolled Asthma: Results of the Phase III ARGON Study
Conclusions: Two doses of IND/GLY/MF fixed-dose combination, single inhaler once-daily showed either comparable or better efficacy vs SFC twice-daily + Tio once-daily (“loose” combination, two inhalers). Both IND/GLY/MF q.d. doses showed non-inferiority with respect to improvements in quality of life vs SFC high-dose b.i.d. + Tio q.d. IND/GLY/MF high-dose q.d. showed greater improvements in lung function and asthma control vs SFC high-dose b.i.d. + Tio q.d. IND/GLY/MF medium-dose q.d. showed comparable improvements in lung function and asthma control vs SFC high-dose b.i.d. + Tio q.d. with a reduced steroid exposure.
Title – Once-Daily Indacaterol Acetate, Glycopyrronium Bromide, and Mometasone Furoate as a Fixed-Dose Combination in Japanese Patients with Inadequately Controlled Asthma: A Multicenter, 52-Week Safety Study
Conclusions: Once-daily IND/GLY/MF high-dose was well-tolerated in Japanese patients with inadequately controlled asthma with no new or unexpected safety signals observed. Sustained and clinically meaningful improvements were observed in lung function and asthma control throughout the study.
Title – Indacaterol/Mometasone Furoate Fixed-Dose Combination Improves Lung Function and Decreases Exacerbations Compared with Salmeterol/Fluticasone in Patients with Uncontrolled Asthma: Pooled Analyses of PALLADIUM and IRIDIUM Studies
Conclusion: This pre-specified pooled analysis of two Phase III studies indicates that IND/MF high-dose q.d. improves lung function and reduces asthma exacerbations as compared to SFC high-dose b.i.d. in patients with uncontrolled asthma. IND/MF medium-dose q.d. resulted in comparable improvements in lung function and reductions in exacerbations versus SFC high-dose b.i.d, with a reduced steroid burden.
Title – Once-Daily Indacaterol Acetate and Mometasone Furoate Fixed-Dose Combination for Treatment of Inadequately-Controlled Asthma: Long-Term Safety Study in the Japanese Population
Conclusions: Treatment with once-daily IND/MF high-dose was well-tolerated in Japanese patients with inadequately-controlled asthma with no new or unexpected safety signals observed. Sustained and clinically meaningful improvements in lung function and asthma control were observed throughout the study.