Barcelona (ots/PRNewswire) -
- In Addition to Effects on Allergic Rhinitis (Hayfever),
GRAZAX(R) Demonstrated Significant Reductions in Asthma Symptoms in
Children Aged 5 to 16 Years Old
ALK-Abelló today presented successful results from a new clinical
trial, GT-12, designed to measure the impact of GRAZAX(R) on allergic
rhinitis and allergic asthma. GT-12 compared the effects of GRAZAX(R)
with symptomatic medication versus symptomatic medication alone on
the ability to reduce symptoms of allergic rhinitis and seasonal
A significant reduction of asthma symptoms was demonstrated.
GRAZAX(R) reduced the combined asthma symptom score by 64%. The
asthma symptoms included were: coughing, wheezing, chest
tightening/shortness of breath (dyspnoea) and exercise-induced
symptoms. Participants in the study also experienced a 67% reduction
in the number of days with asthma symptoms (median).
The study also showed that fewer children required asthma
medication when using GRAZAX(R) than those on symptomatic medication
alone, however these results were not statistically significant.
"The results are particularly relevant as rhinocojunctivitis is
known to be a marker for subsequent development of asthma. Thus
hayfever patients who suffer asthma symptoms maybe at risk of
worsened asthma outcomes and developing clinically diagnosed asthma
if they do not seek treatment," said Prof Albrecht Bufe, lead
investigator of the study.
"GRAZAX(R) has the potential to provide a new treatment choice in
this area particularly among young patients whose symptoms may not be
controlled adequately with available treatments," he continued.
In addition, study results also demonstrated that GRAZAX(R)
reduced hay fever symptoms by 28% and reduced the need for
symptom-relieving medication by 65% (median values) during the grass
pollen season (using a threshold of 30 grains/m3).
The results show comparable effect to the results from the
largest clinical trial programme in adults ever conducted within
allergy immunotherapy which led to a European marketing approval of
the product in 2006.
Currently a registration application for the pediatric use of
GRAZAX(R) is under submission in Europe.
Correlation between Rhinitis and Asthma
Allergies often come in a series called the "allergic march". A
proportion of adults and children with one type of allergy, such as
grass pollen (the most common) will progress to have other allergies
and/or asthma later in life. Thus, the development of allergic
diseases may have life-long implications on the quality of life.
Guidelines recommend treating allergies and keeping a watchful
eye out for other symptoms related to lower airways disease.
Symptomatic medications (e.g. antihistamines and local steroids) aim
only at controlling the symptoms of hayfever temporarily but do not
treat the actual cause of the disease.
GRAZAX(R) is the first immunotherapy tablet that treats the
underlying cause of grass pollen allergy and not only the symptoms.
Only immunotherapy targets the underlying cause of the allergic
disease, having the potential to result in long-term remission. (i)
Several controlled clinical studies have also demonstrated the
added benefits of immunotherapy in treating asthma symptoms in
patients suffering from allergic asthma, and in preventing the
development new allergies and asthma.(ii)(iii)
In particular, Novembre et al. demonstrated that sublingual
(under the tongue) immunotherapy over three years not only improved
seasonal rhinitis symptoms but also reduced the development of
seasonal asthma in children with hay fever.(iv)
While long term studies are still being conducted on GRAZAX(R),
the GT-12 results with GRAZAX(R) in children show significant effects
on asthma symptoms supporting hopes for a way to 'halt' the allergic
Grass pollen allergy is a health problem representing a
significant social burden. At least 75 million people in the USA and
Europe suffer from grass pollen allergy in the form of allergic
rhinitis (hay fever) or allergic asthma - or both.
The majority of patients are only offered symptom-relieving
medications that reduce symptoms temporarily but do not treat the
allergy itself. In addition, 60-68% of patients using
symptom-relieving medications perceive them to be in the range of
'not at all effective' to 'moderately effective' on individual
symptoms, according to a survey conducted by the European Federation
of Allergy and Airway Diseases Patients Associations (EFA).(v)
GRAZAX(R) is a fast-dissolving, once-daily tablet-based allergy
vaccine for home administration. The efficacy and safety of GRAZAX(R)
has been documented in the largest adult clinical study programme
ever conducted within allergy vaccination.
ALK-Abelló is devoted to improving the lives of people with
allergies by developing pharmaceutical products that target the cause
of allergy. ALK-Abelló is the world leader in allergy vaccination
(immunotherapy) - a unique treatment that induces a protective immune
response which reduces and potentially halts the allergic reaction.
Allergy vaccination is traditionally administered as subcutaneous
injections or sublingual droplets. ALK-Abelló aims to extend the use
of allergy vaccination by introducing convenient, tablet-based
vaccines, thereby offering many more patients a causal allergy
treatment. GRAZAX(R), the world's first tablet-based vaccine against
grass pollen allergy, was launched in Europe in 2006, and ALK-Abelló
has entered into partnerships regarding the tablet program with the
Menarini Group for central and Eastern Europe and with
Schering-Plough for North America. ALK-Abelló has more than 1,400
employees with subsidiaries, production facilities and distributors
worldwide. The company is headquartered in Hørsholm, Denmark and
listed on the OMX Nordic Exchange Copenhagen. Further information is
available at http://www.alk-abello.com and http://www.GRAZAX.com.
GRAZAX(R) is a trademark owned by ALK-Abelló A/S.
(i) Linneberg A, Nielsen NH, Madsen F, Frolund L, Dirksen A,
Jorgensen T. Increasing prevalence of specific IgE to aeroallergens
in an adult population: two cross-sectional surveys 8 years apart:
the Copenhagen Allergy Study. J Allergy Clin Immunol
(ii) Bousquet J, Van Cauwenberge P, Khaltaev N. Allergic rhinitis
and its impact on asthma. J Allergy Clin Immunol 2001;108(5
(iii) Jacobsen L CT, Anderson P, Valovirta E, Dahl R, de Monchy
J. The co-morbidity of allergic hay fever and asthma in randomly
selected patients with respiratory allergic diseases. Allergy
(iv) Novembre E, Galli E, Landi F, Caffarelli C, Pifferi M, De
Marco E, et al. Coseasonal sublingual immunotherapy reduces the
development of asthma in children with allergic rhinoconjunctivitis.
J Allergy Clin Immunol 2004;114(4):851-7
(v) EFA web site. 2008.
For further information, please contact:
Sharmi Albrechtsen, International Brand Communication Manager,
Jacob Frische, Director,
ALK-Abelló Group Communications,
Phone +45-45747551 or +45-22247551
ots Originaltext: ALK-Abello
Im Internet recherchierbar: http://www.presseportal.ch
For further information, please contact: Sharmi Albrechtsen,
International Brand Communication Manager, ALK-Abelló, Phone
+45-45747551; Jacob Frische, Director, ALK-Abelló Group
Communications, Phone +45-45747551 or +45-22247551