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Eisai insomnia drug Dayvigo wins US FDA approval

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Eisai insomnia drug Dayvigo wins US FDA approval

Eisai Co. Ltd. said the U.S. Food and Drug Administration approved its drug Dayvigo for treating insomnia in adults.

The Tokyo-based drugmaker said the U.S. regulator gave the nod to Dayvigo, or lemborexant, as a therapy for insomnia characterized by difficulties with sleep onset and maintenance. Insomnia is the most common sleep disorder, affecting 30% of the adult population globally.

Lemborexant works by acting on the orexin neurotransmitter system, which regulates a person's wakefulness. Eisai was previously collaborating with Purdue Pharma LP on the medicine, but the Japanese company took over sole development of the drug in May after the latter became embroiled in a series of lawsuits over the U.S. opioid epidemic.

Eisai's application for Dayvigo was based on the results of two phase 3 trials called Sunrise 1 and Sunrise 2, which enrolled about 2,000 patients.

Eisai is also seeking Japanese and Canadian approval for Dayvigo.