Lundbeck to file NDA and MAA for a major depressive disorder drug

H. Lundbeck A/S (OMX: LUN) said the statistically significant data of its multimodal antidepressant drug candidate Lu AA21004 from Phase III provides a basis for regulatory filing. The compound was compared vs. placebo in the treatment of major depressive disorder of MDD. Lundbeck says taht data from eight of out 10 short-term pivotal studies shows repeated statistical significance in reducing depression symptoms vs. placebo. It has also conducted a long term relapse-prevention study in MDD, confirming positive efficacy.

Lundbeck’s partner Takeda plans to file for US registration in H2 2012 and Lundbeck aims to submit the package for European and Canadian registration around the same time. The drug was generally well tolerated at increased doses. Thus far around 5000 individuals have received the drug. The companies also aim to continue to investigate the compound in cognitive dysfunction in depression.