INGELHEIM, Germany - Monday, September 8th 2014 [ME NewsWire]
Data
show Spiriva® Respimat® reduced the risk of patients having a severe
asthma exacerbation** by 21% when used as add-on therapy in patients who
have symptoms despite taking current standard treatment†1
Almost one
in two patients with asthma still experience symptoms while receiving
current treatment options,2,3,4 putting them at increased risk of
potentially life-threatening asthma exacerbations5
The regulatory
acceptance of Spiriva® Respimat® in asthma establishes a new class of
treatment – no new inhaled treatment class has been approved in asthma
for over a decade6
(BUSINESS WIRE)-- For media outside the US, the UK & Canada only
Boehringer
Ingelheim today announced that the indication for Spiriva® (tiotropium)
Respimat®* in asthma has been accepted by the regulatory authorities in
the EU. Spiriva® Respimat® is indicated as an add-on maintenance
bronchodilator treatment in adult patients with asthma who are currently
treated with the maintenance combination of inhaled corticosteroids
(≥800µg budesonide/day or equivalent) and long-acting beta2-agonists and
who experienced one or more severe exacerbations in the previous year.
The
new indication for Spiriva® Respimat® in asthma is based on the
UniTinA-asthma® large-scale, Phase III clinical trial programme which
investigated adults with asthma who continued to have symptoms despite
taking at least ICS‡ or ICS/LABA§ therapy.
New Phase III data from
the UniTinA-asthma® programme presented today at The European
Respiratory Society International Congress 2014 showed that Spiriva®
Respimat® as an add-on treatment to ICS/LABA maintenance therapy:
Significantly improved asthma symptoms7 - patients were 68% more likely to improve asthma control compared to usual care alone8
These
new results add to existing evidence from the pivotal Phase III studies
with patients on ICS/LABA therapy that demonstrated the addition of
Spiriva® Respimat®:
Reduced the risk of patients having a severe asthma exacerbation by a fifth (21%)1
reduced the number of patients who experienced a severe asthma exacerbation1
Reduced the risk of patients’ asthma worsening by nearly a third (31%)1
The Phase III study results also showed that the safety of Spiriva® Respimat® is balanced as compared to placebo.1
Asthma
is often seen as an easy to manage condition, and the misperception may
exist that people with asthma symptoms can lead a normal life. However,
patients who experience asthma symptoms have about a six times greater
chance of having a potentially life-threatening asthma attack over the
next few weeks than those with minimal-to-no daytime symptoms.5 Their
physical, social and professional lives can also be affected
significantly.9
“We know that, despite taking current treatment
options, almost half of those with asthma still experience
symptoms,2,3,4 which can put them at a significantly increased risk of
an asthma attack.5 These statistics clearly highlight the critical need
for new and effective asthma treatments such as Spiriva® Respimat®,”
said Professor David Halpin, Consultant Physician & Honorary
Associate Professor, Royal Devon & Exeter Hospital.
“Over the
past decade, not much has changed in the range of therapies that we can
offer patients so this new indication for Spiriva® Respimat® is an
important and welcome advance in the treatment of asthma. Its unique
mode of action in asthma provides physicians with a new option to help
improve symptoms and reduce the number of patients who experience asthma
exacerbations and worsenings that are not only frightening and very
unpleasant, but can also be life-threatening,” Professor Halpin
concluded.
Spiriva® Respimat® is an inhaled, long-acting,
anticholinergic maintenance treatment. It works by opening airways and
helping to keep them open for at least 24 hours.10,11,12 There are
currently no other long-acting anticholinergic bronchodilators indicated
for the treatment of asthma. Spiriva® Respimat® is already approved for
the treatment of chronic obstructive lung disease (COPD), with
comprehensive clinical trial data from more than 230 tiotropium COPD
trials.13
“With more than 90 years of experience in the field of
respiratory diseases, Boehringer Ingelheim is committed to bringing new
treatment options to physicians and patients, particularly in areas of
high unmet medical need. Asthma affects millions of patients across
Europe,14 most people with asthma have low expectations of what can be
achieved by asthma management and don’t realise that their condition can
be improved,15” said Professor Klaus Dugi, Chief Medical Officer,
Boehringer Ingelheim.
"The regulatory acceptance of Spiriva®
Respimat® in asthma establishes a new class of inhaled asthma therapy.
Our extensive studies have demonstrated that Spiriva® Respimat® can help
to improve outcomes for adult patients with asthma who remain
symptomatic despite current standard treatments. In the clinical trials
completed, Spiriva® Respimat® in asthma reduced healthcare utilisation,
particularly in relation to the treatment of exacerbations,” Professor
Dugi added.
For more detailed information please follow the links below:
About Spiriva® Respimat® in asthma: http://bit.ly/1untlmF
To view the 'notes to editors' and 'references': http://bit.ly/1vVD7PG
*
Tiotropium Respimat® for use in asthma is currently being reviewed by
regulatory authorities; it is approved as Spiriva® Respimat® for use in
asthma in Chile, Colombia, Ecuador, Norway, Russia and Thailand and
accepted in the EU. Spiriva® Respimat® is indicated as an add-on
maintenance bronchodilator treatment in adult patients with asthma who
are currently treated with the maintenance combination of inhaled
corticosteroids (≥800 µg budesonide/day or equivalent) and long-acting
beta2-agonists and who experienced one or more severe exacerbations in
the previous year
** defined as a deterioration of asthma symptoms
that requires initiation or at least a doubling of systemic
glucocorticoids for ≥3 days
† at least inhaled corticosteroid (ICS) plus long-acting beta2-agonist (LABA) therapy
‡ Inhaled corticosteroids
§ Long-acting beta2-agonists
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Linda Calandra
Phone: +49 151 1502 1148
Email: linda.calandra@boehringer-ingelheim.com
Permalink: http://me-newswire.net/news/12003/en
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