Date: 2012-03-02
Type of information:
phase:
Announcement:
Company: ALK (Denmark)
Product: Grazax® (immunotherapy tablet)
Action mechanism:
Disease: grass pollen induced allergic rhinitis
Therapeutic area: Allergic diseases - Immune diseases
Country:
Trial details:
Latest
news: ALK has announced the publication of a scientific article by professor Durham et al. on the sustained effect on allergy symptoms of Grazax® after completion of three years of treatment.
The article is published in the American Journal of Allergy and Clinical Immunology and highlighted as the editor's choice. The trial is the only published large double-blind placebo-controlled trial to demonstrate that grass allergy immunotherapy tablets (AIT) is an efficacious treatment for grass pollen induced allergic rhinitis with sustained effect for at least two years after treatment completion. This long-term trial is the first and largest double-blind placebo-controlled trial to demonstrate that grass allergy immunotherapy tablets (AIT) is an efficacious treatment for allergic rhinitis and that it induces long-term clinical and immunological tolerance. The newly published data demonstrates consistency throughout the three-year treatment period and the two years following treatment completion. The trial was conducted in eight European countries during 2004-2010. Grazax® is the most extensively documented allergy immunotherapy product currently available and considerable post-marketing experience has been achieved.
GRAZAX® has also been shown to alleviate symptoms of asthma in children and the product is currently being investigated in the GRAZAX® Asthma Prevention (GAP) trial involving 800 children.
Grazax® was approved in Europe in 2006 and is currently marketed in all major European markets. ALK's partner, Merck, holds the exclusive product rights in North America. Merck has submitted a registration application for grass AIT to Health Canada and plans to submit a registration application for grass AIT to the FDA in 2013.
