Regulatory Filings • Nov 22, 2007
Regulatory Filings
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Summary: The Phase III clinical study (GT-12) of GRAZAX® for children met its primary endpoint. The study showed a statistically significant clinical effect corresponding to the results which led to a European marketing approval for adults in 2006. The study concurrently confirmed the known safety profile. In 2008, ALK-Abelló intends to apply for an expansion of the marketing approval to include children and adolescents.
ALK-Abelló has completed a Phase III clinical study (GT-12) of its tablet-based vaccine against grass pollen allergy, GRAZAX® , in children. The study was conducted with a view to obtaining an expansion of the European marketing approval from 2006 to include children and adolescents.
The study was conducted in Germany and included 253 patients from 5 to 16 years of age. The study met its primary endpoint and showed a statistically significant clinical effect corresponding to the results from the comprehensive European clinical development program in adult patients. The study concurrently confirmed the previously documented safety profile.
ALK-Abelló considers the results an important milestone in its development program for tablet-based allergy vaccines to include the treatment of the large group of children and adolescents who suffer from grass pollen allergy.
Based on the results, ALK-Abelló expects to file a variation application with the European regulatory authorities in 2008 with a view to expanding the marketing approval to include children and adolescents.
This announcement does not change ALK-Abelló's financial outlook for 2007.
Hørsholm, November 22, 2007
Jens Bager President and CEO
For further information, please contact: Jens Bager, President and CEO, telephone +45 4574 7576
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