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The results of a study on children confirmed the efficacy of the ORALAIR® Grasses sublingual desensitisation product, which is due to receive German market authorisation shortly
ANTONY CEDEX, France | November 28, 2007 | The results of a study on children confirmed the efficacy of the ORALAIR® Grasses sublingual desensitisation product, which is due to receive German market authorisation shortly.
The phase III paediatric study, VO52.06, which was carried out on 280 patients in 5 European countries suffering from allergic rhino-conjunctivitis, fully met the main evaluation criterion by demonstrating a statistically significant reduction in symptoms, comparable to that observed in the VO34.04 adult study.
Based on this study, STALLERGENES will request the indication of the ORALAIR® Grasses market authorisation to be extended to children.
In addition, results of the first long term adult study (VO53) will be available by the end of the year.
STALLERGENES is confident in the commercial launch of ORALAIR® Grasses in Europe.
At the same time, as part of the Company’s expansion in the US, the proposal for two phase III clinical studies in the US (adults and children), planned for 2009, was received favourably by the FDA and American experts. Talks with potential partners are ongoing.
All these items will be subject to an information meeting on 10 December 2007.
The phase III paediatric study, VO52.06, which was carried out on 280 patients in 5 European countries suffering from allergic rhino-conjunctivitis, fully met the main evaluation criterion by demonstrating a statistically significant reduction in symptoms, comparable to that observed in the VO34.04 adult study.
Based on this study, STALLERGENES will request the indication of the ORALAIR® Grasses market authorisation to be extended to children.
In addition, results of the first long term adult study (VO53) will be available by the end of the year.
STALLERGENES is confident in the commercial launch of ORALAIR® Grasses in Europe.
At the same time, as part of the Company’s expansion in the US, the proposal for two phase III clinical studies in the US (adults and children), planned for 2009, was received favourably by the FDA and American experts. Talks with potential partners are ongoing.
All these items will be subject to an information meeting on 10 December 2007.
SOURCE: Stallergenes |
