Idorsia’s insomnia drug available in first European countries

Idorsia’s first drug on the market offers a new targeted mechanism of action that decreases overactive wakefulness in chronic insomnia disorder. QUVIVIQ will be used for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning.  

QUVIVIQ was approved by the US Food and Drug Administration (FDA) in January 2022, and subsequently made commercially available in May 2022. In April 2022, marketing authorization of QUVIVIQ was granted by the European Commission and subsequently by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.

Jean-Paul Clozel, MD and Chief Executive Officer, commented: “We are determined to revolutionize the treatment of chronic insomnia disorder and advance the science of sleep around the globe. QUVIVIQ which is now the first dual orexin receptor antagonist available to patients in Europe, is the result of more than 20 years of research in our labs. I am very happy that Italian and German patients can now benefit from the targeted mechanism of this drug. The unique characteristics of QUVIVIQ, notably with the 50 mg dose, offer patients with chronic insomnia disorder not only a better night sleep, both in terms of sleep onset and duration, but also an improvement in daytime functioning.”

Simon Jose, Chief Commercial Officer of Idorsia, commented: “We see a significant opportunity for QUVIVIQ as the first and only dual orexin receptor antagonist available to the millions of patients suffering from chronic insomnia disorder in Europe. There are very different payer environments in Europe, as well as different approaches to the treatment of insomnia across countries, and we have developed innovative, country-specific strategies to make QUVIVIQ a success in each market. Physicians and patients across Europe have told us that they are very excited by the prospect of what QUVIVIQ can bring to the treatment of this debilitating condition. The Idorsia teams are engaging with payers and physicians to explain the growing evidence that demonstrates the unique value of QUVIVIQ and what it can bring to patients and to society.”

(Press release / SK)
Picture: Idorsia Pharmaceuticals