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Eisai has bought the rights to investigational drug lemborexant from Purdue Pharma, ending a global development and commercialisation alliance signed in 2015.
The NDA submission was based on data from the clinical development program including two pivotal Phase 3 studies of lemborexant - SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303).
Eisai and its partner Purdue Pharma have submitted new drug application to the US Food and Drug Administration (FDA) seeking approval for lemborexant to treat insomnia, a sleep disorder.....