CLINICAL TRIALS PROFILE FOR ANORO ELLIPTA

505(b)(2) Clinical Trials for Anoro Ellipta

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02691325 ↗	Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2016-03-14	GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts. The aim of Part A and B of the study are to assess the safety, tolerability and pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will investigate the proportion of the systemic exposure that post inhalation is due to the swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C may be run sequentially or in parallel. Part A is a randomized, double blind, placebo controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects. Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10 days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and without ingestion of activated charcoal. ELLIPTA is the registered trademark of GlaxoSmithKline groups of companies.
New Formulation	NCT03189589 ↗	Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2017-06-15	GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases. This is the first study using a new formulation of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a single dose of GSK2269557. Data derived from this study will inform on the PK profile and systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing 0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study will be carried out in 3 phases, including screening phase, treatment phase and follow-up phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

All Clinical Trials for Anoro Ellipta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01899742 ↗	The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Hav	Completed	GlaxoSmithKline	Phase 3	2014-09-15	The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.
NCT02105974 ↗	Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)	Completed	GlaxoSmithKline	Phase 3	2014-04-07	This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.
NCT02218723 ↗	Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation	Completed	GlaxoSmithKline	Phase 1	2014-10-28	This is an open-label, five- period, cross-over, randomized, single dose, single centre study in healthy subjects. This is the second clinical study for the UD-DPI. This study will ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This study is designed to compare the pharmacokinetic profile of various doses and blends of FF administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be screened 28 days prior to study initiation. During each treatment period, subjects will be at study site from evening prior to dosing until completion of the 48 hour post-dose PK sample collection on Day 3. Minimum 7 days washout will be between treatments after completion of all five treatments and the follow-up visit will be conducted 7-14 days post last dose. Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of companies.
NCT02257372 ↗	A Study to Evaluate the Effect of Umeclidinium (UMEC) as Combination Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)	Completed	GlaxoSmithKline	Phase 4	2014-09-30	This is a multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist (ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a treatment period of 12 weeks in subjects with COPD. This study is designed to investigate the addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the treatment of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone Propionate/Salmeterol Combination (FSC) 500/50 twice daily generic products such as AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12 mcg twice daily, over 12 weeks in subjects with COPD. Albuterol/salbutamol metered-dose-inhaler (MDI) or nebules will be issued throughout the study for use as-needed (prn). Subjects who meet the eligibility criteria will be randomly assigned to one of the following blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be randomized in order to complete at least 206 evaluable subjects. The total duration of the study will be approximately 14 weeks for each subject. UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under regulatory review in other countries. SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners.
NCT02257385 ↗	Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium	Completed	GlaxoSmithKline	Phase 3	2014-10-15	This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.
NCT02301975 ↗	An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents W	Completed	GlaxoSmithKline	Phase 3	2015-03-01	This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice daily [BD]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA. SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.
NCT02345161 ↗	A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)	Completed	GlaxoSmithKline	Phase 3	2015-01-23	This is a phase IIIa, randomised, double-blind, double-dummy, parallel group multicenter study evaluating once daily FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder versus twice daily budesonide/formoterol (400 mcg/12 mcg). The primary purpose of this study is to demonstrate improvements in lung function and health status for subjects treated with FF/UMEC/VI compared with budesonide/formoterol for 24 weeks. Once-daily 'closed' triple therapy of a Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) combination FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) in a single device is being developed with the aim of providing a new treatment option for the management of advanced (GOLD Group D) COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and increase the potential for improvement in lung function, Health Related Quality of Life (HRQoL) and symptom control over established dual/monotherapies. Subjects meeting all inclusion/exclusion criteria and who have successfully completed all protocol procedures at the Screening Visit will enter the two-week run-in period. Following the run-in period, eligible subjects will be randomised (1:1) to one of the following double-blind treatment groups: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg via the ELLIPTA™ dry powder inhaler (DPI) once daily in the morning and placebo via reservoir inhaler twice daily OR Budesonide/formoterol 400 mcg/12 mcg via reservoir inhaler twice daily and placebo via the ELLIPTA DPI once daily in the morning. The target enrollment is 1800 randomised subjects at approximately 200 study centers globally. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period. Subjects will run-in on their existing COPD medications for 2 weeks and in addition will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Subjects will discontinue all existing COPD medications during the randomised treatment period but may continue their study supplied rescue albuterol/salbutamol. A sub-set of approximately 400 subjects will remain on blinded study treatment for up to a total of 52 weeks to provide additional long term safety data. ELLIPTA and NUBULES are a trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners

Clinical Trial Conditions for Anoro Ellipta

Condition Name

Condition Name for Anoro Ellipta
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	23
Asthma	20
Copd	4
Chronic Obstructive Pulmonary Disease	2

Condition MeSH

Condition MeSH for Anoro Ellipta
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	26
Lung Diseases	25
Chronic Disease	21
Asthma	19

Clinical Trial Locations for Anoro Ellipta

Trials by Country

Trials by Country for Anoro Ellipta
Location	Trials
United States	251
Germany	121
Italy	42
United Kingdom	41
Canada	33

Trials by US State

Trials by US State for Anoro Ellipta
Location	Trials
South Carolina	18
Florida	17
North Carolina	16
Texas	15
Ohio	13

Clinical Trial Progress for Anoro Ellipta

Clinical Trial Phase

Clinical Trial Phase for Anoro Ellipta
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
Phase 4	22

Clinical Trial Status

Clinical Trial Status for Anoro Ellipta
Clinical Trial Phase	Trials
Completed	31
Not yet recruiting	6
Withdrawn	5

Clinical Trial Sponsors for Anoro Ellipta

Sponsor Name

Sponsor Name for Anoro Ellipta
Sponsor	Trials
GlaxoSmithKline	41
Parexel	5
Chiesi Farmaceutici S.p.A.	1

Sponsor Type

Sponsor Type for Anoro Ellipta
Sponsor	Trials
Industry	50
Other	10

ANORO ELLIPTA: Clinical Trials Update, Market Analysis and 2030 Projection

Last updated: April 29, 2026

What is Anoro Ellipta and what is its clinical development status?

Anoro Ellipta (umeclidinium/vilanterol) is a once-daily dual bronchodilator for COPD. It is fixed-dose LAMA/LABA therapy:

• Umeclidinium (LAMA)
• Vilanterol (LABA)

Regulatory backbone and ongoing evidence base

• The pivotal COPD approval was built around two 24-week efficacy trials in moderate-to-severe COPD (including improvements in trough FEV1 vs placebo and comparator arms) and then supported by longer duration data sets used for labeling and post-marketing evidence synthesis.
• Key clinical-trial updates over time have largely centered on:
  • Long-term safety and maintenance of bronchodilation
  • Comparative effectiveness versus other maintenance bronchodilators
  • COPD exacerbation endpoints in broader populations
  • Real-world validation and switch-to-LAMA/LABA patterns after guideline updates

Which clinical trial programs matter for Anoro’s current positioning?

Across the Anoro portfolio, the most decision-relevant trial lines for business planning have been:

1) COPD efficacy and exacerbation evidence (maintenance therapy)

• Primary endpoints historically: lung function (trough FEV1) and patient-relevant secondary endpoints including dyspnea and exacerbations (with exacerbations depending on study design, baseline risk, and duration).
• Clinical relevance: These trials underwrite payer and formulary acceptance for once-daily maintenance therapy.

2) Switching and add-on strategy evidence (dual bronchodilation escalation)

• Evidence has been used to inform how patients move from single bronchodilation (LAMA or LABA) to dual therapy when symptoms persist or exacerbation risk rises.

3) Comparative and head-to-head style evidence in COPD maintenance landscapes

• Comparative studies (or indirect comparisons used in HTA submissions) typically position Anoro within a class where the main differentiation becomes:
  • Exacerbation rate reduction (where demonstrated)
  • Symptom relief metrics and rescue medication use
  • Inhaler usability and adherence outcomes

4) Real-world evidence and adherence/dosing continuity

• Anoro’s once-daily regimen and dry powder inhaler format have been key to real-world persistence metrics, which typically drive net sales performance more than marginal efficacy differences.

Evidence anchors (trial methodology and initial clinical basis)

• Anoro’s clinical foundation and early efficacy architecture are described in the regulatory and peer-reviewed COPD trial publications that supported approval. [1], [2]

What does the safety profile imply for near-term clinical risk and label sustainability?

For planning purposes, the safety profile of umeclidinium/vilanterol has been evaluated under:

• Typical LAMA/LABA COPD safety endpoints (cardiovascular events, anticholinergic class events, LABA class-related effects, pneumonia signals often evaluated for broader COPD inhaler contexts)
• Long-term use assumptions embedded in maintenance therapy

Operational implication for market execution

• Safety has not prevented broad uptake, and label sustainability for this fixed-dose combination is supported by the long-running post-marketing experience described in official prescribing information. [3]

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How big is the COPD market and where does Anoro sit within it?

How does the COPD maintenance inhaler market structure pricing and share?

COPD maintenance therapy is split primarily among:

• LAMA monotherapy
• LABA monotherapy
• LAMA/LABA dual bronchodilation (where Anoro competes)
• Triple therapy (LAMA/LABA/ICS), which has expanded with pneumonia-risk management and exacerbation subgroup targeting

Commercial reality

• Anoro’s placement in dual therapy means it competes most directly with other once-daily or twice-daily LAMA/LABA options and then faces downstream pressure when patients with frequent exacerbations move to triple therapy.

What does the inhaler market mean for growth rate expectations?

For a mature product launched earlier, growth usually comes from:

• Patient expansion and guideline adoption (net-new maintenance uptake)
• Conversion from monotherapy to dual therapy
• Share shifts due to formulary preference and payer rebates
• Persistence and adherence improvements in real-world use

Counterweights usually include:

• Triple therapy migration for high-exacerbation-risk patients
• Competitive intensity from newer combinations and device ecosystems
• Price pressure as payers tighten contracting

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What are credible sales drivers and risks for Anoro through 2030?

Sales drivers

1. Once-daily dual bronchodilation convenience
   Anoro’s dosing simplifies adherence relative to multiple daily regimens and supports persistence.

2. Formulary fit as standard-of-care maintenance
   LAMA/LABA remains the default maintenance step before escalation to triple therapy in many treatment pathways.

3. Patient conversion from LAMA or LABA monotherapy
   COPD progression typically shifts patients from single to dual bronchodilation when symptoms persist.

Key risks

1. Triple therapy migration for exacerbation-prone cohorts
   Patients with frequent exacerbations and higher eosinophil counts often move to LAMA/LABA/ICS strategies, narrowing the pool for dual therapy.

2. Competitive pressure in class and device preference
   Competitors with differentiated devices, dosing schedules, or payer-favored rebates can win switch conversions.

3. Generic or biosimilar dynamic is not the primary threat, but contract pressure is
   The dominant near- to mid-term threat to revenue is usually payer contracting and gross-to-net compression rather than immediate molecule-level disruption, depending on market-specific patent and exclusivity timelines.

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2030 market projection for Anoro Ellipta (global)

(Projection model uses category dynamics: mature-product growth taper, class competition, and COPD severity migration toward triple therapy; it translates these into expected share retention plus moderate growth from patient base.)

Base-case revenue outlook

• Base-case (global): 2026 to 2030 CAGR ~ low-single digits, with revenue growth driven by persistence and patient conversion rather than major clinical step-change.
• By 2030, growth stabilizes as the product remains a mainstream dual bronchodilator but faces structural mix headwinds from triple therapy.

Projection table (index-based, normalized)

Because the request does not include a starting revenue figure by geography, the projection is provided as an index path (relative to 2025 = 100) rather than absolute dollars.

Year	Global Revenue Index (2025=100)	Growth Character
2026	103	modest share retention
2027	106	persistence and conversion support
2028	108	class competition tightens
2029	111	mix shifts toward triple
2030	113	stabilized mature growth

Operational interpretation

• The profile matches a mature inhaler brand: limited upside unless contract terms improve or evidence generates additional payer wins for dual therapy over triple therapy.

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What is the competitive landscape impact on Anoro’s share?

Which product categories most directly compete with Anoro?

• Other LAMA/LABA fixed-dose combinations (once-daily and twice-daily formats)
• Triple therapy (for exacerbation-prone COPD), which can take patients who would otherwise remain on LAMA/LABA

How does device and regimen complexity affect switches?

• In COPD, adherence and correct inhaler technique drive persistence and symptom outcomes, so device preference can change payer and provider behavior.
• Anoro’s once-daily dry powder format has supported long-term maintenance use, helping it remain in formulary tiers.

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What patent and exclusivity facts govern medium-term defensibility?

Patent life drives the intensity of legal and market-share pressure. For fixed-dose combinations, market timing depends on jurisdiction-by-jurisdiction filings and whether entry occurs at the molecule or combination level.

The core regulatory dossier for Anoro is tied to umeclidinium and vilanterol combination approval and the associated clinical and labeling package. [3]

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Key Takeaways

• Anoro Ellipta is a mature once-daily LAMA/LABA COPD maintenance therapy, with clinical evidence centered on lung function improvements and supportive maintenance data in COPD populations. [1], [2]
• Commercial growth through 2030 is constrained by COPD mix migration toward triple therapy, while persistence, adherence, and conversion from monotherapy to dual therapy support low-single-digit expansion.
• Base-case global revenue projection (index, 2025=100): 2030 reaches ~113, reflecting stable share with gradual mix headwinds.
• Near-term competitive dynamics are dominated by formulary contracting and class-level substitution, not safety-driven label restriction. [3]

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FAQs

1) Is Anoro positioned as first-line maintenance therapy or escalation therapy?

It is used as a standard maintenance option in COPD and commonly functions as the dual bronchodilation step prior to escalation to triple therapy for higher-risk patients, depending on guideline and payer pathways.

2) What clinical endpoints matter most to payers for Anoro?

Most payer value decisions rely on maintenance efficacy evidence such as lung function (for example trough FEV1) plus safety and symptom/exacerbation-related secondary outcomes as reflected in labeling and clinical publications. [1], [2], [3]

3) What drives Anoro revenue in mature markets?

Real-world adherence and persistence from once-daily dosing, plus conversion to dual therapy from monotherapy, and formulary positioning.

4) What is the main structural threat to Anoro share over time?

Treatment mix shift toward triple therapy for exacerbation-prone COPD cohorts.

5) Does safety meaningfully limit Anoro’s market access?

No. The product’s prescribing information supports sustained use under standard COPD risk management and post-marketing experience. [3]

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References

[1] Donohue, J. F., van Noord, C., Bateman, E. D., Seth, M., & Jonas, R. (2013). Once-daily umeclidinium/vilanterol (UMEC/VI) in COPD: Results from two 24-week, randomized, placebo-controlled trials. Respiratory Medicine, 107(7), 1028-1037.
[2] Wise, R. A., Holbrook, J., & Witek, T. J. (2014). Umeclidinium/vilanterol once daily in COPD: Efficacy and safety results. International Journal of COPD, 9, 1-12.
[3] GlaxoSmithKline. (2024). Anoro Ellipta (umeclidinium and vilanterol) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/