Takeda Pharmaceutical Company Limited (TSE: 4502)(“Takeda”) and its partner, H. Lundbeck A/S (“Lundbeck”) today announced the submission of a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults. MDD is a complex but common disorder with more than 3.5 million cases in Japan, affecting 3percent of the population[i].
The NDA filing included data from the pivotal phase III randomized, placebo-controlled study (NCT02389816) in MDD. Approximately 490 Japanese adults with recurrent MDD were randomized to receive vortioxetine (10 and 20 mg) or placebo. The primary endpoint was the change from baseline (i.e. the start of double-blind treatment) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score after 8 weeks of treatment. The study demonstrated positive results of vortioxetine as compared to placebo for the treatment of MDD in adults. Full results will be presented at a scientific meeting in the future. The regulatory submission also featured data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147).
“MDD is a multifaceted condition that has emotional, physical and cognitive symptoms. As such, it represents a significant medical need.” said Naoyoshi Hirota, head of Takeda Development Center Japan. “We are pleased by today’s regulatory filing as it demonstrates our joint commitment with Lundbeck, and our belief that vortioxetine has the potential to become a new treatment option for patients in Japan suffering from this serious and complex condition.”
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