This edition presents key opinion leader (KOL) views on recent developments in the COPD market. Topics covered include; Novartis’ December 2016 publication of positive results from the CRYSTAL study, which explored the effects of switching patients from standard therapies to the long-acting muscarinic antagonist/long-acting beta antagonist (LAMA/LABA) dual combination therapy Ultibro/Ultibron (indacaterol/glycopyrronium) and how these results fit with the latest Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations; the future launch of the first triple combination therapies for the treatment of COPD, in light of Chiesi’s and GSK/Innoviva’s regulatory filings in late 2016; and KOL views on positive Phase III data reported by Theravance Biopharma and Mylan in respect of the novel nebulized LAMA therapy, revefenacin.
*Latest* Update 3: Jan 2017
Update 2: October 2016
Update 1: July 2016
Original Publication: April 2016
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This update tackles these key questions
- In December 2016, Novartis’ published positive results from the CRYSTAL switch study with the long-acting muscarinic antagonist/long-acting beta antagonist (LAMA/LABA) dual combination therapy Ultibro/Ultibron (indacaterol/glycopyrronium; Novartis/Vectura), but what impact will the data have in terms of clinical practice?
- Novartis’ CRYSTAL study further supports latest Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations that bronchodilators should be used as first line therapy, but will these guidelines be followed in clinical practice and where will inhaled corticosteroids (ICS) now sit in the COPD treatment paradigm?
- Will generic versions of GSK’s ICS/LABA therapy Seretide/Advair (fluticasone/salmeterol), which are expected to launch in Europe and the US in 2018, undermine GOLD recommendations for bronchodilation as preferred therapy, as payers look to contain costs?
- The first triple combination ICS/LAMA/LABA therapies are pending regulatory approval, but how well will patients and prescribers receive them, and how will they be used in the treatment of COPD?
- GSK, Chiesi and AstraZeneca all have triple combination therapies nearing launch, but what factors will differentiate them in terms of clinical uptake?
- Following Theravance Biopharma and Mylan reporting positive Phase III data for its novel once-daily nebulized LAMA therapy, revefenacin, what benefits does this product offer over existing therapies?
- If approved, how will revefenacin be used in the treatment of COPD, and which patients will this product appeal to?
This edition presents key opinion leader (KOL) views on recent developments in the chronic obstructive pulmonary disease (COPD) market. Topics covered include Chiesi Pharmaceuticals’ European marketing application for the first closed triple combination product in the treatment of COPD. Latest Phase III data from the FULFIL clinical trial pertaining to GlaxoSmithKline/Innoviva’s closed triple combination therapy, presented at the European Respiratory Society (ERS) International Congress 2016. The perceived impact of the latest clinical trial data concerning Novartis’ dual bronchodilator, Ultibro Breezhaler, presented at the ERS International Congress 2016.
This edition presents key opinion leader (KOL) views on recent developments in the chronic obstructive pulmonary disease (COPD) market. Topics covered include the clinical relevance of the latest clinical trial data presented by GlaxoSmithKline (GSK) at the 2016 American Thoracic Society International Conference in San Francisco, California (ATS 2016) in respect of two of the company’s dual-combination products for the treatment of COPD: the ICS/LABA Breo Ellipta (fluticasone furoate/vilanterol) and the LABA/LAMA Anoro Ellipta (vilanterol/umeclidinium). KOLs’ views on the perceived clinical benefits of several closed triple-combination therapies, currently in late-stage development, are also explored.
Original Publication: Is the COPD treatment market poised for a fundamental shift?
After years of dominance by a handful of brands, change is in the air for COPD treatment. Will deep set preferences finally be overturned, or will physicians need both cost and performance incentives to switch? How will device attributes impact future decision-making? Which are the key trials to watch and why?
Find out in FirstWord’s new report, COPD: KOL Insight Request sample pages now.
Covering 13 currently marketed brands and 5 Phase III drugs, this report examines today’s market, looks at future trends and reveals insight from 12 key opinion leaders (KOLs) in North America and Europe.
Discover why the ‘open versus closed’ triple therapy debate is set to intensify thanks to exciting new research. With IL-5 antibodies in Phase III development, targeted treatment could soon be a reality. Decide for yourself which brands will be the new ‘movers and shakers’ in COPD treatment – and find out how new studies look set to change entrenched habits.
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“These are provocative results. It shows that for reasons that we don’t understand, long acting bronchodilators are quite effective in decreasing exacerbations. And they are equivalent to an ICS/LABA which suggests that we’re are overusing ICS.”
Expert insight into the COPD treatment landscape
Recently Marketed Drugs
Long-acting muscarinic antagonists (LAMAs)
- Spiriva (tiotropium; Boehringer Ingelheim): Is familiarity enough to keep Spiriva in the top position? Are physicians considering alternatives?
- Eklira/Tudorza (aclidinium; AstraZeneca): Is patient preference for twice-daily dosing a trend to watch?
- Seebri (glycopyrronium; Novartis): How does the efficacy of twice-daily US Seebri compare to the once a day EU version?
- Incruse (umeclidinium; GlaxoSmithKline): Can Incruse beat Spiriva as the LAMA of choice now that comparative studies have revealed its superior lung function performance?
- Arcapta/Onbrez (indacaterol; Novartis): What was behind the 25% drop in sales of Arcapta/Onbrez in 2015?
- Striverdi (olodaterol; Boehringer Ingelheim): Find out why the FDA rejected Boehringer Ingelheim’s attempt to make Striverdi the first COPD brand with exercise endurance benefits.
- Ultibro/Utibron (indacaterol/glycopyrronium; Novartis): Will the Ultibro FLAME trial redefine the treatment path for patients with exacerbations, with ICS added as a last resort?
- Anoro (umeclidinium/vilanterol; GSK): Where next for Anoro? IF GSK’s companion triple ICS/LAMA/LABA is approved, will Anoro’s easy treatment sequencing trump all else?
- Stiolto/Spiolto (tiotropium/olodaterol; Boehringer Ingelheim): If KOLs view all LAMA/LABAs as comparable, what is Stiolto/Spiolto’s differentiator?
- Duaklir (aclidinium/formoterol; AstraZeneca): Will device differences between Duaklir and other AstraZeneca products create a drug sequencing issue?
- Symbicort (budesonide/formoterol; AstraZeneca): Can Symbicort catch up with Advair? Do KOLs favour MDIs or DPIs?
- Advair/Seretide (fluticasone propionate/salmeterol; GSK): When are US generics expected? Will payers prefer low cost Breo/Relvar to generic Advair/Seretide?
- Breo/Relvar (fluticasone furoate/vilanterol; GSK): Was pricing or clinical benefit behind the trebling of Breo/Relvar sales last year?
Pipeline DrugsAnti-IL5 antibody
- Benralizumab (AstraZeneca): Do KOLs believe the clinical benefit of benralizumab will be enough to justify the expected cost?
- Mepolizumab (GSK): How important are eosinophil levels for patient selection? Will differing views about the minimum level be an issue for mepolizumab?
Closed triple (ICS/LAMA/LABA)
- PT010 (AstraZeneca): Is improved lung function or reduced exacerbations the primary focus for current studies with PT010?
- CHF5993 (Chiesi): KOLs say adherence is the key benefit of closed triples; will two separate 52-week studies for CHF5933 throw any more light on this issue?
- FF/UMEC/VI (GSK): With so much at stake, what exactly does GSK hope to gain from extensive trials of its FF/UMEC/VI closed triple?
- Reluctance to switch: KOLs view all LAMAs and LAMA/LABAs as equivalent and still believe ICS are an important treatment option for recurrent exacerbations. Concerns about the unknown effect of withdrawal of ICS will prevent physicians from changing existing patient therapies. Will this slow the growth of LAMA/LABAs?
- Potential overuse of ICS: The first comparative trial of LAMA/LABA versus ICS/LABA (the FLAME study) looks like a game-changer. GSK’s much anticipated IMPACT study may settle once and for all the optimal treatment approach. Will continuing uncertainty regarding asthma vs. COPD in primary care continue to prompt ICS use?
- KOLs want earlier detection: Late presentation is common as early symptoms such as a cough can be missed in primary care settings. Diagnosis often follows exacerbations or significant loss of lung function. How will spirometry be leveraged in the future?
- Belief that closed triples will simply improve adherence: With ICS/LAMA/LABA combinations expected to be approved in 2018, KOLs are focused on the benefits of a simplified treatment path rather than any clinical advantages. But will payers agree?
- Unmet needs remain: Existing therapies reduce symptoms and exacerbations, but none slow the progressive decline in lung function or reduce mortality. Other needs such as improving drug adherence and identifying predictive biomarkers are being addressed to some degree. Where next for the treatment of COPD?
- The importance of the device: KOLs are uninspired by device choices. Although they recognise an impact on adherence, most do not have favourites; drug choice is the deciding factor. Triple combinations via one device could be a step forward. GSKs plans for consistency of device across the entire treatment pathway could have far-reaching implications.
- Questions about established treatment pathways: GOLD guidelines provide little clarity. New studies are offering a different perspective on entrenched choices. LAMA/LABA combinations may prove to be more effective for some patients than ICS/LABA. Closed triples are simpler for patients. Eosinophils may be a promising biomarker.
- Individual preference as a key driver: Are incremental benefits enough to challenge entrenched prescribing habits? KOLs also consider cost, adherence and patient preferences before switching. As none of the drug companies can yet promise to cure COPD, is symptomatic relief and reducing exacerbations the only choice on offer?
A report based on expert knowledge
Key Opinion Leaders Interviewed for This Report
North American KOLs
- Prof Robert Wise, MD; Johns Hopkins Medical School, US
- Prof David Mannino, MD; Head of Pulmonary Care, Critical Care, and Sleep Medicine, University of Kentucky in Lexington, KY
- Prof Richard H Casaburi, MD; Chief, Division of Respiratory and Critical Care Physiology and Medicine, University of California at Los Angeles Medical Center
- Prof James Donahue, MD; Professor of Medicine, UNC Chapel Hill Medical Center
- Prof Nadia Hansel, MD; Associate Professor of Medicine, Johns Hopkins University School of Medicine
- Prof Fernando Martinez, MD; Adjunct Professor, Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, University of Michigan
- Prof Fan Chung, MD; Professor of Respiratory Medicine & Head of Experimental Studies, National Heart & Lung Institute, Imperial College London, UK
- Professor Anoop Chauhan, MD; Consultant Physician in Respiratory and General Medicine, Portsmouth Hospitals NHS Trust, UK
- Prof Stefano Centanni; MD; University Hospital Milan, Italy
- Three anonymous German KOLs
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