Idorsia’s QUVIVIQ (daridorexant) Recommended for Approval in Europe as a New Treatment for Adults with Insomnia Disorder

Idorsia Ltd has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion for the use of QUVIVIQ (daridorexant) as the first dual orexin receptor antagonist in the European Union (EU) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning.

Idorsia said in its press release that the positive CHMP opinion is supported by robust pivotal Phase 3 data, recently published in The Lancet Neurology, which demonstrated that daridorexant improved nighttime symptoms and daytime functioning in adults with insomnia disorder at months one and three compared to placebo, with a favorable safety profile. The efficacy and safety of QUVIVIQ are further supported by a long-term follow-up extension study, which together with the pivotal trials, provides clinical data for up to 12 months of continuous treatment.

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented:
“The recommendation from the CHMP is an important milestone for Idorsia and a significant step towards delivering a new treatment option for European patients with insomnia disorder. If approved, QUVIVIQ would not only be the first dual orexin receptor antagonist made available in Europe, but also the first insomnia medicine to improve daytime functioning. In addition, with periodic reassessment of the need for therapy, QUVIVIQ can be used for long-term treatment, addressing a key limitation of existing therapies. This is represented in the unique indication adopted by the CHMP, for patients who have considerable impact on daytime functioning, and for those who have been experiencing difficulty sleeping for an extended period. I am very proud that Idorsia will be the company to effect real change across Europe by bringing this innovation to patients.”

Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of functioning. This impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep, the company explained.

Professor Ingo Fietze, University Hospital Berlin, commented:
“The Phase 3 program with daridorexant was the first to comprehensively measure the impact of pharmacological treatment on all aspects of the condition, including daytime functioning as perceived by patients. Results demonstrated that daridorexant not only significantly improved sleep onset, sleep maintenance and total sleep time in adults with insomnia disorder, but also patients’ daytime functioning, all while maintaining a favorable safety profile. Having the evidence that treatment can provide benefits on both nighttime symptoms and daytime functioning without the limitations associated with existing insomnia treatments, such as rebound insomnia upon discontinuation of treatment, withdrawal symptoms, risk of dependence, or next-morning residual effects, is going to completely change the treatment landscape for our patients.”

Professor Luigi Ferini-Strambi, Vita-Salute San Raffaele University, Milan, commented:
“Insomnia affects between 6 and 12% of the adult population in Europe. For patients with insomnia disorder, the medical condition can have a negative impact on many aspects of daily life from studying and employment to social activities and relationships. It can also have a significant economic impact due to an increased risk for injuries and motor vehicle accidents, as well as reduced workplace productivity. This CHMP recommendation marks an important step in changing the lives of patients with insomnia disorder across Europe.”

QUVIVIQ is a dual orexin receptor antagonist, 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, the company explained.

The CHMP has adopted a positive opinion for the use of QUVIVIQ 50 mg for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. In addition, QUVIVIQ 25 mg will be available for specific patient populations, e.g. taking certain concomitant drugs, the company said.

The positive opinion recommending QUVIVIQ, is a scientific recommendation issued by the EMA’s CHMP, which is sent to the European Commission (EC) for the adoption of a decision on an EU-wide marketing authorization. An EC marketing authorization through the centralized procedure is valid in all European Union Member States, as well as the European Economic Area countries Iceland, Liechtenstein and Norway, and Northern Ireland under the Northern Ireland Protocol.

For Great Britain, a separate application for the use of daridorexant for the same indication will immediately be made to the Medicines and Healthcare products Regulatory Agency (MHRA) via the European Commission Decision Reliance Procedure, a post-Brexit, temporary administrative process, under which the MHRA will rely on the decision taken by the EC on the approval of the product, the company said.

Daridorexant is currently under review with Swissmedic and Health Canada. In January, QUVIVIQ (daridorexant) was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with insomnia.