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Lundbeck says Phase III results support NDA submission for depression treatment candidate

Monday, May 14 2012 | Comments
Evidence Grade 0 What's This?
H. Lundbeck A/S said the New Drug Application (NDA) for Lu AA21004 in the treatment of adults with major depressive disorder (MDD) would be based on the positive outcomes recently observed in three Phase III trials of the drug.

Two of the trials were conducted in the United States and one was conducted primarily in Europe.

In one of the U.S.-based studies, 614 patients were randomized to receive once-daily treatment with 15 mg or 20 mg of Lu AA21004, 60 mg of Eli Lilly and Co.'s Cymbalta (duloxetine hydrochloride) or placebo. The other U.S. study included 462 patients who received a daily regimen of 10 mg or 20 mg of Lu AA21004 or placebo. In the European study, 600 patients were randomized to receive Lu AA21004 15 mg/day and/or 20 mg/d.

When compared with placebo, Lu AA21004 statistically significantly reduced depression symptoms among the study participants and was generally well-tolerated.

Overall, eight out of 10 large, placebo-controlled studies of Lu AA21004 completed in patients with MDD have "shown effect" of Lu AA21004, the company noted.

The trial data are undergoing further analysis and are expected to be presented at upcoming medical conferences.

In light of the current data, Lundbeck and its partner on the drug, Takeda Pharmaceutical Co. Ltd., plan to submit an NDA for Lu AA21004 to the Food and Drug Administration later this year. Lundbeck also plans to submit applications this year to European and Canadian regulatory authorities seeking approval of Lu AA21004 for MDD.

This information concerns a use that has not been approved by the FDA.

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