Novartis first in class once-daily dual bronchodilator Ultibro® Breezhaler® (QVA149) gains positive CHMP opinion for the treatment of COPD
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Novartis International AG /
Novartis first in class once-daily dual bronchodilator Ultibro® Breezhaler®
(QVA149) gains positive CHMP opinion for the treatment of COPD
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The issuer is solely responsible for the content of this announcement.
* QVA149 (indacaterol/glycopyrronium) is the first once-daily fixed-dose
combination of both a LABA and a LAMA bronchodilator to gain positive CHMP
opinion
* Pivotal Phase III IGNITE data showed QVA149 significantly improved lung
function and patient-reported outcomes including breathlessness and rescue
medication use, compared to current standard of care[1]
* QVA149 demonstrated significantly reduced rates of COPD exacerbations and
improved health-related quality of life compared to open-label tiotropium
18 mcg and glycopyrronium 50 mcg[2],[3]
Basel, July 26, 2013 - Novartis announced today that the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion for approval of once-daily Ultibro(®) Breezhaler(®
)(indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110
mcg/50 mcg metered dose per capsule), as a maintenance bronchodilator treatment
to relieve symptoms in adult patients with chronic obstructive pulmonary disease
(COPD). Ultibro Breezhaler was developed under the name of QVA149.
"The CHMP's positive opinion supports a major breakthrough in the treatment of
COPD, where many patients do not have adequate treatment options," commented
David Epstein, Division Head, Novartis Pharmaceuticals. "QVA149 has shown
significant improvements compared with some of the most commonly used treatment
options for COPD, which is projected to be the third leading cause of death by
2020."
QVA149 is an investigational fixed dose combination of two bronchodilators,
indacaterol, a long-acting beta(2)-adrenergic agonist (LABA) and glycopyrronium,
a long-acting muscarinic antagonist (LAMA).
QVA149 significantly improved the rate of all exacerbations compared to open-
label (OL) tiotropium 18 mcg, glycopyrronium 50 mcg and was comparable to
salmeterol/fluticasone (SFC) 50 mcg/500 mcg[3]. The rate of moderate or severe
exacerbations was significantly lower compared to glycopyrronium 50 mcg and
numerically lower compared to OL tiotropium 18 mcg[2],[3].
In clinical studies, QVA149 demonstrated an acceptable safety profile with no
meaningful differences between the treatment groups (placebo, indacaterol 150
mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, SFC 50 mcg/500 mcg) in the
incidence of adverse and serious adverse events[2],[4],[5].
The European Commission generally follows the recommendations of the CHMP and
normally grants a marketing authorization within three months of the opinion.
Worldwide submissions and reviews of QVA149 are ongoing with US filing expected
at the end of 2014.
About the IGNITE clinical trial program
In the Phase III IGNITE clinical trial program, QVA149 is being investigated for
the treatment of COPD patients as an inhaled, once-daily, fixed-dose combination
of indacaterol maleate and glycopyrronium bromide. IGNITE is one of the largest
international clinical trial programs in COPD comprising 11 studies in total
(ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE,
LANTERN, FLAME) with more than 10,000* patients across 52 countries[3],[6]-
[9],[10]-[17]. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN,
SPARK, BLAZE, ARISE, BEACON) completed in 2012. The studies were designed to
investigate the efficacy, safety and tolerability, lung function, exercise
endurance, exacerbations, shortness of breath and quality of life in patients
treated with QVA149.
Results from five of the Phase III IGNITE trials[3],[6]-[9]supported the CHMP's
positive opinion for QVA149 which demonstrated statistically significant
improvements in bronchodilation versus treatments widely used as current
standards of care[1]. Data showed that QVA149 significantly improved
bronchodilation compared to OL tiotropium 18 mcg, SFC 50 mcg/500 mcg,
indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo providing a rapid
onset within five minutes, and sustained bronchodilation during a 24 hour period
which was maintained for up to 26 weeks, along with symptomatic
improvements[1],[3],[7],[8]. These symptomatic improvements included
breathlessness, exercise tolerance, rescue medication use and health-related
quality of life[3],[4],[5],[6].
*Total refers to all 11 IGNITE studies.
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.
Onbrez(®) Breezhaler(® )(indacaterol maleate) is a long-acting beta(2)-agonist
(LABA) that offers clinically relevant 24 hour bronchodilation combined with a
rapid onset of action within five minutes at first dose, as demonstrated in the
INERGIZE Phase III trial program[18]-[32]. Onbrez Breezhaler 150 mcg once-daily
provided greater clinical benefit in terms of reduced shortness of breath, lower
use of rescue medication and improved health status, compared with blinded
tiotropium bromide 18 mcg[28]. Onbrez Breezhalerwas first approved and launched
in the EU (150 mcg and 300 mcg once-daily doses) for maintenance bronchodilator
treatment of airflow obstruction in adult patients with COPD[33]. It has now
received approvals in approximately 100 countries around the world including
Japan (as Onbrez(® )Inhalation Capsules 150 mcg once-daily) and USA (as
Arcapta(TM) Neohaler(TM )75 mcg once-daily).
Once-daily Seebri(®) Breezhaler(®) (glycopyrronium bromide) is a novel inhaled
long-acting muscarinic antagonist (LAMA; also referred to as a long-acting
anticholinergic) indicated as a maintenance bronchodilator treatment to relieve
symptoms in adult patients with COPD[34]. Glycopyrronium bromide was exclusively
licensed to Novartis in April 2005 by Vectura and its co-development partner
Sosei. In Phase III studies (GLOW 1, 2 and 3) Seebri Breezhaler (glycopyrronium
50 mcg) once-daily demonstrated rapid improvements in lung function after first
dose on Day 1 which was sustained for 24 hours and maintained over the 52 week
study period compared with placebo. Glycopyrronium 50 mcg also significantly
improved shortness of breath, health-related quality of life, exacerbation risk,
and exercise endurance versus placebo[35].[36],[37]. Seebri Breezhaler is
approved in the EU, Japan, Switzerland, Canada, Australia and a number of other
countries.
Novartis continues development of respiratory products for delivery via a
single-dose dry powder inhaler (SDDPI) called the Breezhaler(®) device which has
low air flow resistance, making it suitable for patients with airflow
limitation[38]. The Breezhaler(®) device allows patients to hear, feel and see
that they have taken the full dose correctly[34].
Novartis is committed to addressing the unmet medical needs of COPD patients and
improving their quality of life by providing innovative medicines and devices.
About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe,
with symptoms that have a destructive impact on patients' function and quality
of life[39],[40]. It affects an estimated 210 million people worldwide and is
projected to be the third leading cause of death by 2020[40],[41]. COPD is often
considered to be a disease of later years, but estimates suggest that 50% of
those with COPD are now less than 65 years old, resulting in increases in
absenteeism, premature retirement and reductions in workforce participation[42].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "positive CHMP opinion," "projected," "investigational,"
"generally follows," "normally grants," "ongoing," "expected," "is being
investigated," "designed to," "committed," "continues development," or similar
expressions, or by express or implied discussions regarding potential marketing
approvals for Ultibro Breezhaler or regarding potential future revenues from
Ultibro Breezhaler. You should not place undue reliance on these statements.
Such forward-looking statements reflect the current views of management
regarding future events, and involve known and unknown risks, uncertainties and
other factors that may cause actual results to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Ultibro Breezhaler will be approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that Ultibro Breezhaler will achieve any particular levels of revenue
in the future. In particular, management's expectations regarding Ultibro
Breezhaler could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected additional
analysis of existing clinical data; competition in general; government, industry
and general public pricing pressures; unexpected manufacturing issues; the
company's ability to obtain or maintain patent or other proprietary intellectual
property protection; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as recorded in
the Group's consolidated balance sheet, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. 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.
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,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
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the world. For more information, please visit http://www.novartis.com.
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Datum: 26.07.2013 - 13:45 Uhr
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