-
New analyses from the FLAME
study suggest dual bronchodilator Ultibro®
Breezhaler® provides
similar or better efficacy versus steroid-containing therapies,
regardless of blood eosinophil (a type of white blood
cell) counts
-
Data was published in the
centenary issue of the American Thoracic Society's 'American
Journal of Respiratory and Critical Care Medicine'
-
Together with the International
Primary Care Respiratory Group, Novartis is launching physician
guidance to support a deeper evaluation of inhaled steroid use in
COPD patients
Basel, May 23, 2017 - Further
analyses of Novartis' head-to-head FLAME study suggest that inhaled
corticosteroids (ICS) may not be needed in some chronic obstructive
pulmonary disease (COPD) patients with high blood eosinophil (a
type of white blood cell) counts. The new data showed that
Ultibro®
Breezhaler® consistently
provided superior or similar benefits over Seretide®* in COPD
patients regardless of the eosinophil count[1]. These results
contrast with data suggesting better clinical outcomes with ICS
therapies for patients with high eosinophil counts[2]-[5]. The data
was published in the centenary issue of the American Thoracic
Society's 'Blue Journal'**[1] and solidifies the need for
individualized risk-benefit assessments when considering ICS
treatments.
The potential for high blood eosinophil counts to
be considered as a biomarker to direct the use of a LABA***/ICS
combination over dual bronchodilation (LABA/LAMA****) in some
patients, has been referenced in the 2017 GOLD (Global Initiative
for Chronic Obstructive Lung Disease) report[6]. FLAME was the
first trial to prospectively study the influence of blood
eosinophils on the efficacy of ICS-containing therapies versus a
LABA/LAMA. The new analyses showed that once-daily Ultibro
Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to
twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in
reducing exacerbations (flare-ups), independent of a blood
eosinophil count above or below 2%[1]. In addition, at no cut-off
was Seretide more effective than Ultibro Breezhaler[1].
"These new FLAME study analyses provide evidence
that an effective dual bronchodilator such as Ultibro Breezhaler
can provide similar or better benefits in patients with high
eosinophil counts who may have been considered for an inhaled
steroid-containing treatment," said Vasant Narasimhan, Global Head
Drug Development and Chief Medical Officer for Novartis. "The data
highlight the opportunity to allow more patients to avoid
unnecessary exposure steroid-containing regimens and the
significant potential associated risks."
With funding support from Novartis, the
International Primary Care Respiratory Group (IPCRG) is addressing
the appropriate use and safe withdrawal of ICS in COPD patients
with the launch of a primary care physician guide. The guide was
launched at the recent IPCRG conference in Slovenia and aims to
ensure the latest evidence based treatment guidance from the 2017
GOLD report is translated into daily clinical practice. The guide
is accessible on the IPCRG website here: https://goo.gl/FlSVck
About FLAME
FLAME is a randomized, double-blind, double-dummy, parallel-group,
non-inferiority, active-controlled 52-week study involving 3,362
COPD patients and conducted at 356 sites across 43
countries[7].
Results published in the New
England Journal of Medicine[7] confirmed that Ultibro
Breezhaler (indacaterol/glycopyrronium) 110/50 mcg met its primary
endpoint (non-inferiority) and furthermore demonstrated superiority
to Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg on the rate
of all COPD exacerbations (mild/moderate/severe) over one year of
treatment in COPD patients with a history of at least one
exacerbation in the previous year. Against further secondary
endpoints, Ultibro Breezhaler was also superior compared to SFC in
reducing or improving the following[7]:
-
Rate and time to first moderate or severe COPD
exacerbation
-
Time to first COPD exacerbation
(mild/moderate/severe)
-
Time to first severe COPD exacerbation
-
Lung function (trough FEV1)
-
Health-related quality of life (St. George's
Respiratory Questionnaire)
The pre-specified analyses of data from the FLAME
study compared treatment efficacy according to blood eosinophil
percentage (<2% and >=2%, <3% and >=3%, and <5% and
>=5%) and absolute blood eosinophil count (<=150 cells/ Mu l,
150 to <300 cells/ Mu l, and >=300cells/ Mu l)[1].
FLAME is part of the IGNITE Phase III clinical
trial program exploring Ultibro Breezhaler for the treatment of
COPD
About the Novartis COPD
portfolio
Novartis is committed to addressing the unmet medical needs of COPD
patients and improving their quality of life by providing
innovative medicines and devices. The Novartis COPD portfolio
includes Ultibro®
Breezhaler®
(indacaterol/glycopyrronium bromide), Seebri®
Breezhaler®
(glycopyrronium bromide) and Onbrez®
Breezhaler®
(indacaterol), which are all indicated as maintenance treatments
for COPD patients. Glycopyrronium bromide and certain use and
formulation intellectual property were exclusively licensed to
Novartis in April 2005 by Sosei and Vectura.
Novartis continues development of respiratory
products for delivery via the low resistance Breezhaler inhalation
device, which makes it suitable for patients with different
severities of airflow limitation[8]. The Breezhaler device allows
patients to hear, feel and see that they have taken the full dose
correctly[8],[9].
About COPD
Chronic obstructive pulmonary disease (COPD) affects an estimated
210 million people worldwide[10] and is the third leading cause of
death[11]. It is progressive (usually gets worse over time) and can
be a life-threatening disease[10],[12]. COPD makes it difficult to
breathe, with symptoms that have a destructive impact on patients'
function (i.e. activity limitation, decreased mobility) and quality
of life[10],[12].
Exacerbations are a sudden
worsening of COPD symptoms that can be frightening for patients,
causing distress, anxiety and quality of life deterioration[13].
COPD exacerbations are also associated with significant healthcare
resource burden and costs[14], particularly due to the frequent
need for hospitalization. Consequently, the prevention of
exacerbations is an important goal in COPD management to improve
long-term health status and conserve healthcare resources[15].
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by words such as "potential," "suggest," "launching,"
"suggesting," "can," "may," "addressing," "launch," "launched,"
"aims," "committed," "continues," or similar terms, or by express
or implied discussions regarding potential new indications or
labeling for Ultibro Breezhaler or the other products in the
Novartis COPD Portfolio, or regarding potential future revenues
from Ultibro Breezhaler and the other products in the Novartis COPD
Portfolio. You should not place undue reliance on these statements.
Such forward-looking statements are based on the current beliefs
and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties.
Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may
vary materially from those set forth in the forward-looking
statements. There can be no guarantee that Ultibro Breezhaler or
any of the other products in the Novartis COPD Portfolio will be
submitted or approved for any additional indications or labeling in
any market, or at any particular time. Nor can there be any
guarantee that Ultibro Breezhaler or any of the other products in
the Novartis COPD Portfolio will be commercially successful in the
future. In particular, management's expectations regarding Ultibro
Breezhaler and the other products in the Novartis COPD Portfolio
could be affected by, among other things, the uncertainties
inherent in research and development, including clinical trial
results and additional analysis of existing clinical data;
regulatory actions or delays or government regulation generally;
the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry
conditions; global trends toward health care cost containment,
including ongoing pricing and reimbursement pressures; safety,
quality or manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. Novartis is providing
the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
Notes
* Seretide®
Accuhaler®
(salmeterol/fluticasone) 50 microgram /500 microgram /dose
inhalation powder. Seretide and Accuhaler are registered trademarks
of the GlaxoSmithKline group of companies
** American Journal of Respiratory and Critical Care
Medicine
*** Long-acting beta2-adrenergic agonist
**** Long-acting muscarinic antagonist
About Novartis
Novartis provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 118,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Roche N, Chapman K, Vogelmeier C, et al. Blood Eosinophils and
Response to Maintenance COPD Treatment: Data from the FLAME Trial.
Am J Respir Crit Care Med. 2017;195:9:1125-1127.
[2] Pascoe S, et al. Blood eosinophil counts, exacerbations, and
response to the addition of inhaled fluticasone furoate to
vilanterol in patients with chronic obstructive pulmonary disease:
a secondary analysis of data from two parallel randomised
controlled trials. Lancet Respir Med. 2015;3:435-442.
[3] Hinds DR, et al. Identification of responders to inhaled
corticosteroids in a chronic obstructive pulmonary disease
population using cluster analysis. BMJ Open
2016;6:e010099.
[4] Siddiqui SH, et al. Blood Eosinophils: A Biomarker of Response
to Extrafine Beclomethasone/Formoterol in Chronic Obstructive
Pulmonary Disease. Am J Respir Crit Care Med. 2015;
192:523-525.
[5] Pavord ID, et al. Blood eosinophils and inhaled
corticosteroid/long-acting ß-2 agonist efficacy in COPD. Thorax
2016; 71:118-125.
[6] Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Global strategy for the diagnosis, management, and prevention of
chronic obstructive pulmonary disease. Updated 2017. Available at:
http://goldcopd.org/ [Accessed 15 May 2017].
[7] Wedzicha JA, Banerji D, Chapman KR, et al.
Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD.
New England Journal of Medicine. 2016. Available at:
www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May
2017].
[8] Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a
capsule based dry powder inhaler for the delivery of indacaterol.
CMRO. 2010;26;11:2527-2533.
[9] Ultibro Breezhaler EU Summary of Product Characteristics.
Available at: www.medicines.org.uk/emc/medicine/29533 [Accessed 16
May 2017].
[10] Global Alliance Against Chronic Respiratory Diseases (GARD).
Global surveillance, prevention and control of chronic respiratory
diseases: a comprehensive approach. Available at:
http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 16
May 2017].
[11] World Health Organization: The top 10 causes of death fact
sheet No 310.
Available at: http://www.who.int/mediacentre/factsheets/fs310/en/
[Accessed 16 May 2017].
[12] Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Global strategy for the diagnosis, management, and prevention of
chronic obstructive pulmonary disease. Updated 2017. Available at:
http://goldcopd.org/ [Accessed 16 May 2017].
[13] Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic
obstructive pulmonary disease-a patients' perspective. Prim Care
Respir J. 2006;15:2:102-109.
[14] Toy EL, Gallagher K, Stanley E, et al. The economic impact of
exacerbations of chronic obstructive pulmonary disease and
exacerbation definition: a review. COPD. 2010;7:214-28.
[15] Anzueto A. Impact of exacerbations on COPD. European
Respiratory Review. 2010;19:116:113-118.
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