FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia

FDA accepts the new drug application for review of Idorsia’s 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 10, 2021
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia.

Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. 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:
“I’m very happy that this first regulatory hurdle is behind us. This was a huge NDA and the team has done an excellent job in preparing the dossier, on which the FDA can judge the properties and merits of daridorexant. We now stand-by to work with the FDA to answer any questions that might arise concerning the effect of daridorexant on sleep, daytime functioning and its safety profile.”

The NDA 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 in sleep during the night and, for the first time for an insomnia treatment, 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. The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo. Patients reported no next-morning sleepiness compared to placebo as assessed by the morning visual analogue scale (VAS).

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: www.idorsia.com

The NDA was submitted to the US FDA on January 8, 2021 and the MAA to the European Union EMA on March 2, 2021. Should approval be received, the company anticipates launch in the US in the first half of 2022.