HØRSHOLM, Denmark, July 7, 2017 /PRNewswire/ --
- The disease modifying property of
GRAZAX® (SQ®
grass SLIT-tablet) resulted in long-term effect on allergic
rhinoconjunctivitis (ARC) and prevented asthma symptoms, even two
years after end of treatment in children with grass pollen ARC and
no existing signs or symptoms of asthma
- Younger children had a higher probability of developing
asthma. The younger the children were at treatment-start, the
greater the percentage was prevented from having asthma symptoms
and using asthma medication during the two-year follow-up period
post discontinuation of treatment
- Evidence in asthma continues to build for latest generation
of allergy immunotherapy treatments
ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today released
further analysis of data from its landmark five-year
GRAZAX® Asthma Prevention (GAP)
clinical trial in children. The analysis, which appears online in
press in The Journal of Allergy and Clinical Immunology, shows that
the benefits of GRAZAX® in prevention of asthma symptoms
were even more pronounced when treatment was initiated at an
earlier age.
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The GAP trial, which is the largest double-blind,
placebo-controlled trial ever conducted in allergy immunotherapy in
a paediatric population, was initiated in 2009 to investigate the
effect of ALK's sublingual grass allergy immunotherapy (SLIT)
tablet, GRAZAX®, on the risk of developing asthma when
compared with placebo treatment. The trial involved 812 children
aged 5-12 years at 101 sites in 11 European countries and comprised
a three-year treatment phase with a two-year follow-up phase.
The primary trial endpoint was the time to a first diagnosis of
reversible impairment of lung function. The hypothesis was that
fewer children given GRAZAX® would receive this
diagnosis or that they would be diagnosed later than subjects in
the placebo group.
This primary endpoint was not met and the trial indicated that
an appropriate asthma diagnosis in this particular population
should not be based on a single time point evaluation but rather
rely on a combined clinical assessment obtained over a longer
observation period, which is normally done in daily practice.
However, the trial did reveal several advantages of early treatment
of children with GRAZAX®. Including:
- GRAZAX® significantly reduced the proportion of
children experiencing asthma symptoms or using asthma medication -
an effect that was observed year round and sustained for two years
after end of treatment
- The younger the children were at treatment initiation, the
greater the percentage of children avoiding asthma symptoms and the
need for symptomatic asthma medication during the follow-up
period
- The disease modifying effect on ARC in children was
verified
The GAP trial also confirmed that the safety and tolerability of
GRAZAX® were favourable and in line with previous
studies, with no new or unexpected findings.
Erkka Valovirta, Adjunct professor of clinical and paediatric
allergology, University of Turku,
Finland, said: "The landmark GAP trial uncover valuable
data about allergic asthma and the potential for preventing it with
a new class of clinically proven allergy immunotherapy products
such as GRAZAX®. These data illustrates
the importance of early intervention with the right treatment for
children who are at risk of developing this serious
condition."
Asthma affects an estimated 300 million individuals worldwide
and is considered a serious global health problem affecting all age
groups. It is one of the most common chronic childhood diseases and
can impose a considerable burden on patients, their families, and
health care systems. Allergic rhinoconjunctivitis is a recognised
risk factor for asthma development.
GRAZAX® is one of a new generation of allergy
immunotherapy treatments that show benefits in respiratory allergy.
It reduces ARC symptoms and the need for allergy pharmacotherapy.
In addition, the latest GAP data indicate that the disease
modifying properties of GRAZAX® extends to prevent the
development of asthma symptoms in children with grass pollen ARC.
GRAZAX® is today marketed in Europe and Australia as the only product with an ARC
disease modifying effect. In North America GRAZAX® is
available under the brand name GRASTEK®[1].
In 2015, ALK's ACARIZAX® - a sister product to
GRAZAX® used in the treatment of house dust mite allergy
- became the first SLIT-tablet to be approved for use in patients
with house dust mite allergic asthma in Europe. In February
2017, clinical data for ACARIZAX® led, for the
first time, to the addition of allergy immunotherapy as a
recommended additional treatment option in the Global Initiative
for Asthma (GINA) report: Global Strategy for Asthma Management
and Prevention.
ALK-Abelló A/S
About GRAZAX®
GRAZAX® was approved in Europe in 2006 and is today marketed in 27
countries including Australia and
North America.
GRAZAX® is the world's best documented
grass allergy immunotherapy product with data from 17 randomised,
double-blind, placebo-controlled clinical trials, covering more
than 5,600 patients. In North America GRAZAX®
is available under the brand name
GRASTEK®.
About ALK
ALK is a research-driven global pharmaceutical company
focusing on allergy prevention, diagnosis and treatment. ALK is a
world leader in allergy immunotherapy - a treatment of the
underlying cause of allergy. The company has approximately 2,300
employees, with subsidiaries, production facilities and
distributors worldwide. ALK has entered into partnership agreements
with Torii, Abbott, and Seqirus to commercialise sublingual allergy
immunotherapy tablets in Japan,
Russia, and South-East Asia, and Australia and New
Zealand, respectively. The company is headquartered in
Hørsholm, Denmark, and listed on
Nasdaq Copenhagen. Find more information at
http://www.alk.net.
- GRASTEK® trademark is owned by
Merck (NYSE: MRK)
SOURCE ALK