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Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia

Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia

The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on objective and subjective sleep parameters, and an improvement in daytime functioning, while maintaining a favorable safety profile

Allschwil, Switzerland – March 3, 2021
Idorsia Ltd (SIX: IDIA) today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for daridorexant, Idorsia's investigational dual orexin receptor antagonist, for the treatment of adult patients with insomnia.

Insomnia is a common problem with up to 10% of adults having all the symptoms that meet the diagnostic criteria for insomnia disorder. Insomnia, a condition of overactive wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“This European application, following the submission in the US, is an indication of our commitment to transform the treatment of insomnia around the globe. Europe has a high prevalence of insomnia and significant unmet need as the field has not benefited from innovation for many years. Most of the current treatment options are acting on the brain in a non-specific way, with restrictions due to safety concerns. This is the first European marketing application for a dual orexin receptor antagonist and, if approved, daridorexant would be the first insomnia treatment acting by a novel mechanism in decades.”

The MAA includes data from a comprehensive clinical and non-clinical development program. In the Phase 3 registration program, daridorexant showed statistically significant and clinically meaningful improvements not only in sleep duration, but also in patient-perceived sleep quantity and quality, and, for the first time for an insomnia treatment, an improvement in daytime functioning, which were sustained over time.

The Phase 3 program provided a deep understanding of the safety and tolerability profile of daridorexant. Adverse reactions reported with a frequency of ≥ 2% in daridorexant-treated patients and greater (≥ 1%) than in placebo-treated patients in 3-month efficacy trials were headache, somnolence, fatigue, dizziness, and nausea. Patients reported no next-morning sleepiness compared to placebo as assessed by the morning visual analogue scale (VAS). The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo.

These results make daridorexant the first sleep medication to demonstrate an improvement in sleep and daytime functioning, as measured by a newly developed and validated instrument, while keeping a favorable safety profile in adult and elderly patients.

In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. More details and commentary can be found in the dedicated press releases (first study release), (second study release) and the investor webcasts (first study webcast), (second study webcast) which are available for replay on Idorsia’s corporate website:

The NDA was submitted to the US FDA on January 8, 2021. Should approval be received, the company anticipates launch in the US in the first half of 2022.

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Last Updated: 03-Mar-2021