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February 12, 2013
06:58 EDTVNDAVanda Pharmaceuticals to submit Tasimelteon NDA in mid-2013
In December 2012 and January 2013, Vanda announced positive results for two Phase III studies for tasimelteon in the treatment of Non-24. The SET Phase III study demonstrated that tasimelteon was able to entrain the master body clock as measured by melatonin and cortisol circadian rhythms. Vanda plans to submit an NDA to the FDA in mid-2013. Vanda will meet with the FDA in Q1 of 2013 for a pre-NDA meeting on tasimelteon in the treatment of patients with Non-24.Vanda has decided to discontinue all activities related to the MDD indication. In January, Vanda announced that the MAGELLAN Phase IIb/III clinical study in MDD did not meet the primary endpoint of a change from baseline in the Hamilton Depression Scale after 8 weeks of treatment as compared to placebo. Vanda has formally appealed the EMA's negative opinion for Fanaptum and requested a re-examination of the decision by the EMA's Committee for Medicinal Product for Human Use.
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