Idorsia obtains FDA nod for Quviviq
Idorsia has received the Food and Drug Administration’s green light for Quviviq (daridorexant) in dosage strengths of 25 mg and 50 mg.
The medication is used for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
The Food and Drug Administration has recommended that Quviviq be classified as a controlled substance.
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The product is expected to be available to patients in May 2022.
“After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face,” said Martine Clozel, chief scientific officer of Idorsia. “Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects.”
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Patricia Torr, president and general manager of Idorsia U.S. said, “I am extremely proud to be leading the US organization of such a forward-thinking and patient-centric organization like Idorsia. With this first FDA approval for our company, Quviviq provides a new treatment option that can help adults with insomnia get to sleep faster and stay asleep longer, which we know plays an important role in how they feel the next day. It’s an incredibly exciting time for us and I can’t wait to transform the treatment paradigm in the US. We have a differentiated product, an amazing team, and an innovative strategy, giving me absolute confidence that we can make Quviviq a great success.”