GRAZAX(R) Demonstrates Significant Reductions on Asthma Symptoms in Children
07/06/2008 12:01
PR Newswire
BARCELONA, June 7 /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 asthma.
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 march.
About GRAZAX(R)
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.
About ALK-Abelló
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.
References
(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 2000;106(2):247-52
(ii) Bousquet J, Van Cauwenberge P, Khaltaev N. Allergic rhinitis and its
impact on asthma. J Allergy Clin Immunol 2001;108(5 Suppl):S147-334
(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 2002;57(23).
(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,
ALK-Abelló Phone,
+45-45747551;
Jacob Frische, Director,
ALK-Abelló Group Communications,
Phone +45-45747551 or +45-22247551
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
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