Idorsia submits investigational insomnia treatment daridorexant to the EMA

Swiss biotech company Idorsia has submitted a marketing authorisation application to the European Medicines Agency (EMA) for its investigational insomnia treatment daridorexant.

Daridorexant is a dual orexin receptor agonist (DORA) designed for the treatment of insomnia, by reducing overactive wakefulness associated with the condition.

The marketing authorisation application includes data from Idorsia’s clinical and non-clinical programme for daridorexant.

This includes a Phase III registration programme, within which daridorexant showed statistically significant and clinically meaningful improvements in sleep duration, patient perceived sleep quantity and quality and improvement in daytime function.

Adverse reactions reported in the Phase III trial included headache, fatigue, dizziness and nausea.

Patients reported no next-morning sleepiness compared to placebo, which as assessed by the morning visual analogue scale (VAS).

In addition, the incidence of somnolence (sleepiness) was low and did not increase with daridorexant 50mg compared to placebo.

“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,” said Jean-Paul Clozel, chief executive officer of Idorsia.

“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,” he added.

Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning.

It is a common problem, with up to 10% of adults having all the symptoms that meet the diagnostic criteria for insomnia disorder.