Allschwil, Switzerland — November 15, 2022, Idorsia Ltd(SIX: IDIA) today announced that QUVIVIQ™(daridorexant) is now available in the first batch of European countries, Italy and Germany for the treatment of symptoms lasting for at least three months with a considerable impact on daytime function. 1 Chronic insomnia is one of the most common sleep disorders in Europe, affecting 6%-12% of the adult population and affecting both physical and mental health. 3, 4 _ _
QUVIVIQ is the first dual orexin receptor antagonist (DORA) available to Italian and German patients for the treatment of chronic insomnia. Instead of inducing sleep by broadly suppressing brain activity, QUVIVIQ simply blocks the activation of orexin receptors. 1 Thus, QUVIVIQ reduces the arousal drive and allows sleep to occur without changing the proportion of sleep stages. 1
The recommended dose of QUVIVIQ is 50 mg per pill once a night, taken within 30 minutes of bedtime at night. 1 In some cases, such as in patients with moderate liver function impairment or who are taking a moderate CYP3A4 inhibitor, the recommended dose is 25 mg once per night.
It said: “We are determined to revolutionise the treatment of chronic insomnia and advance the science of sleep globally. QUVIVIQ is now the first dual orexin receptor antagonist available to patients in Europe and is the result of more than 20 years of research in our laboratory. I am delighted that patients in Italy and Germany can now benefit from the targeting mechanism of this drug. The unique properties of QUVIVIQ, especially in the 50 mg dose, may not only provide chronic insomniacs with a better night’s sleep, including the timing and duration of falling asleep, but also improved daytime function.”
“We see QUVIVIQ as the first and only dual orexin receptor antagonist available to the millions of patients in Europe suffering from chronic insomnia as a significant opportunity. With very different payment environments in Europe and different approaches to insomnia from country to country, we have developed innovative, country-specific strategies to make QUVIVIQ successful in every market. Doctors and patients across Europe have told us they are very excited about the prospects QUVIVIQ could offer for treating this debilitating disease. The Idorsia team is working with payers and physicians to interpret the growing evidence of QUVIVIQ’s unique value and what it can deliver for patients and society.”
The results, published in Issue 3 of The Lancet Neurology, showed that QUVIVIQ improved sleep initiation, sleep maintenance and self-reported total sleep time in adults with chronic insomnia at recommended doses. A major focus of the five trials was to assess the impact of QUVIVIQ on daytime function in insomniacs, as assessed by IDSIQ, a patient-reporting outcome tool specifically developed and validated in accordance with FDA guidelines to measure daytime function in patients with insomnia. The recommended dose of QUVIVIQ showed a statistically significant improvement in daytime sleepiness in IDSIQ, meaning that patients reported feeling less mental and physical fatigue, less drowsiness and more energy during the day compared to placebo during the first and third months, with a favorable safety profile. 1,5 In clinical trials, the most commonly reported adverse effects were headache and drowsiness. Most of the adverse reactions were mild to moderate in intensity. 1 There was no evidence of a dose relationship in the frequency or severity of adverse events. 1. The characteristics of adverse reactions in elderly patients were consistent with those in young patients. 1 Sleepiness was reported in 3% and 2% of patients treated with QUVIVIQ 25 mg and 50 mg, respectively, compared with 2% of subjects receiving placebo. 1 Marketing authorisation is also supported by an extended long-term follow-up study, which, along with the pivotal trial, provides clinical data on continuous treatment for up to 12 months.
Research over the past few decades has shown that the process of hyperarousal in the brain plays a key role in the pathology of insomnia. Chronic insomnia is the result of persistent hyperexcitability of the brain and needs to be managed continuously over several months with therapies suitable for everyday use. 7 Orexin is a neuropeptide, a small protein-like molecule produced by the brain that promotes wakefulness. 1, 6 QUVIVIQ reduces excessive wakefulness at night to improve sleep (initiation and maintenance) in insomnia patients without residual effects the next morning, thereby improving daytime function. five
The regulatory status of daridorexant QUVIVIQ
It was approved by the U.S. Food and Drug Administration (FDA) in January 2022 and subsequently launched in May 2022. For more information on QUVIVIQ in the United States, please see the Complete Prescribing Information (PI and Medication Guide). Marketing authorization for QUVIVIQ was approved by the European Commission in April 2022, The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) was subsequently approved through the European Commission’s decision dependence process. For more information on EU QUVIVIQ, please refer to the Summary of Product Characteristics (SmPC). Preparations are underway for the launch in key European markets, with QUVIVIQ launching in Italy and Germany in November 2022. Daridorexant is currently under review by Swissmedic and Health Canada.
Post time: Nov-17-2022