SWITZERLAND – The FDA approved Swiss biotech Idorsia’s first drug, known commercially as Quviviq, for the treatment of adults suffering from insomnia.

The medication belongs to a new class of drugs known as dual orexin receptor antagonists, which work by blocking chemical messengers known as orexins, which are responsible for keeping people awake.

The path to approval for daridorexant, a dual orexin receptor antagonist (DORA), was paved with mostly positive late-stage trials, with both approved doses — 25 mg and 50 mg — showing statistically significant improvements in polysomnography and self-reported total sleep at different stages in one of the two pivotal trials.

The drug is safe in terms of the most common reported adverse reactions, which were headache and fatigue, and the label reflects that, with analysts noting “no Black Box or addiction safety warning,” and no notable risks for the higher dose.

However, Quviviq is unlikely to make an immediate impact on the market, which currently includes two other DORAs from Eisai and Merck.

When it is released, Idorsia’s drug will compete with Merck & Co’s Belsomra, which was approved in 2014, and Eisai Co’s Dayvigo, which was approved in 2019.

Idorsia said its drug won’t be available until May because it needs to be classified as a controlled substance by the US Drug Enforcement Administration, and analysts predict sluggish sales in the first few months.

Insomnia is characterized by difficulty falling asleep or staying asleep, which leads to fatigue, trouble concentrating, and irritability.

Idorsia was spun off from Swiss pharmaceutical company Actelion in early 2017 following a US$30 billion acquisition by Johnson & Johnson.

Idorsia was formerly Actelion’s R&D department and is led by Jean-Paul Clozel, Actelion’s founder and CEO. Three other drugs in Idorsia’s pipeline have progressed to the Phase III stage.

The European Medicines Association is also reviewing Idorsia’s drug, and the company anticipates a decision in the first quarter of 2022.

According to the company, approximately 25 million adults in the United States suffer from insomnia, and 12 million of them take medications to help them sleep.

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