Lu AA21004: Phase III data

Top-line data from a double-blind, U.S. Phase III trial in 614 patients aged 18-75 with MDD showed that Lu AA21004 significantly improved MADRS scores from baseline vs. placebo. Lu AA21004 was generally well tolerated with nausea, headache, diarrhea and vomiting reported as the most common adverse events. Patients received once-daily 15 or 20 mg Lu AA21004, once-daily 60 mg duloxetine or placebo for up to 8 weeks. H. Lundbeck and Takeda plan to submit an NDA to FDA for Lu AA21004 to treat MDD in 2H12. Lundbeck also plans to submit an MAA and an NDS to EMA and Health Canada, respectively, next half. ...