ALK-Abell?? Ltd announced today that Grazax®, grass-pollen allergen tablet, is now available for use in children and adolescents aged 5 to 17.
Grazax is the only non-injection immunotherapy licensed to treat children suffering from severe grass pollen induced seasonal allergic rhinitis and conjunctivitis or severe hay fever1. In addition, it is the first immunotherapy tablet to address the underlying cause of grass pollen allergy2,3. It is a once daily fast-melting tablet which is placed under the tongue (sublingual). Grazax has been available for use in adults in the UK since January 2007.
Clinical research in children taking Grazax plus standard therapy such as antihistamines and nasal steroids resulted in a 22% increase in well days and reduced hay fever symptoms by 27% compared to standard therapy alone, during the peak grass pollen season1. Furthermore, adding Grazax to standard therapy resulted in a 64% reduction in these other medications during the peak grass pollen season1. It was generally well tolerated, with the majority of side effects being transient, local allergic reactions, such as oral pruritus (irritation in the mouth), which was classified as mild to moderate1. Consult the SPC for details of all reported side effects (attached).
Severe allergic rhinoconjunctivitis can affect a child’s future. The peak hay fever season tends to coincide with examination time and children with rhinoconjunctivitis symptoms are 40% more likely to drop a grade between their mock and final GCSE exams compared to those with no symptoms4. Uncontrolled symptoms can also affect sleep, general school performance and social activities5.
Dr Adam Fox, Consultant Paediatric Allergist, London commented on the launch of Grazax for children "Grazax gives us the opportunity to treat the root cause of our patients’ allergy, rather than trying to just manage their symptoms and this makes today’s launch an extremely important event for UK paediatricians and their patients."
Grazax can be considered for use in patients with proven grass pollen allergy and severe rhinoconjunctivitis symptoms which remain uncontrolled despite the use of traditional treatments such as antihistamines and nasal corticosteroids.
Immunotherapy is the only recognised treatment which targets the cause of the allergy and alters the natural course of the disease6. Research has demonstrated that the effects of immunotherapy are long-lasting. One such study showed long-term remission of symptoms for at least 3 years after its discontinuation7 and interim results from a study in adults with Grazax has shown a sustained reduction in symptoms a year after treatment had ceased8.
The NHS price of Grazax is ??67.50 for 30 tablets or ??2.25 per day. A recent health economic study9 has shown Grazax to be a cost-effective strategy in patients suffering from allergic rhinitis with co-existing asthma. The study concluded that "From a socio-economic standpoint, specific immunotherapy with Grazax represents efficient use of NHS resources and should therefore be integrated into the care pathway of patients with moderate-to-severe grass pollen induced asthma and rhinoconjunctivitis in the UK".
1. GRAZAX Summary of Product Characteristics. Available at
2. Malling HJ et al. Safety and immunological changes during sublingual immunotherapy with standardized quality grass allergen tablets. J Investig Allergol Clin Immunol 2006; 16(3):162-168
3. Durham SR et al. Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol 2006; 117:802-809.
4. accutane Isotretinoin Walker SM et al. Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: Case-control study. J Allergy Clin Immunol 2007; 120:381-387.
5. Passalaque G et al. Pediatr Allergy Immunol 2007;18; 40-45.
6. Bousquet J, Lockey RF, Maling HJ. Allergen Immunotherapy: therapeutic vaccines for allergic diseases. WHO position paper. Allergy 1998; 53: 1-42
7. Durham SR et al. Long-term efficacy of grass-pollen immunotherapy.New Engl Jnl of Med 1999; 341:468-75.
8. Data on File 2008. ALK -Abell?? A/S.
9. Nasser S et al. Cost-effectiveness of specific immunotherapy with Grazax in allergic rhinitis co-existing with asthma. Allergy 2006: 63; 1624-1629.
ALK-Abell?? is a research-based pharmaceutical company and a world leader in
allergen specific immunotherapy with more than 80 years of experience in allergy treatment and diagnostics. Headquartered in H??rsholm, Denmark the company employs more than 1,200 employees worldwide.
accutane Isotretinoin
March 8th 2009 Uncategorized
