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H. Lundbeck A/S (Lundbeck) today announced that the first patients have been recruited and dosed in the new phase III programme using Lu AA21004 in major depression (MDD). The first patients have been recruited in Finland.
As previously communicated filing of Lu AA21004 is anticipated in 2012. The extended phase III programme for Lu AA21004 is based on clinical data obtained until now. Available data show encouraging results for the potential efficacy and the tolerability profile of Lu AA21004: A European based 560-patient placebo-controlled MDD study shows statistical significance on the primary efficacy endpoint across all tested doses.
Additionally a 639-patient relapse prevention study shows statistical significance in maintenance of efficacy in long-term treatment of MDD.
Supportive study shows separation from placebo with 5 and 10 mg doses.
Finally, the proof of concept study (clinical phase II) shows statistical significance on all tested doses
The phase III programme aims to recruit patients from Europe, as well as the US and Canada in cooperation with our partner Takeda Pharmaceutical Company Limited (Takeda).
For more information, please click the link below:
Lundbeck
