Idorsia bags US FDA approval of Quviviq

Swiss biotech Idorsia (SIX: IDIA) edged up 2.6% to 20.6 francs in early trading today, after it revealed that the US Food and Drug Administration has approved Quviviq (daridorexant) 25mg and 50mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

The FDA approval of Quviviq is based on an extensive clinical program that included 1,854 adults with insomnia at over 160 clinical trial sites across 18 countries. Insomnia, a serious medical condition, is the most common sleep disorder in the US.

Quviviq is a dual orexin receptor antagonist (DORA), which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.