FDA approves potential blockbuster insomnia drug, a first for Swiss biotech Idorsia
The FDA on Monday approved Swiss biotech Idorsia’s first drug, known commercially as Quviviq, for the treatment of adults with insomnia.
The road to approval for this dual orexin receptor antagonist (DORA) called daridorexant has been lined with mostly positive late-stage trials, with both of the 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.
Safety-wise, the drug is on par with placebo 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.
But Quviviq isn’t likely to make an immediate splash on the market, which includes two other DORAs from Eisai and Merck.
Idorsia said its drug won’t launch until May because it has to be scheduled as a controlled substance by the US Drug Enforcement Administration, and analysts think the early months will bring tepid sales too.
“Despite perhaps ‘best case’ US FDA label, we still see commercial execution risks, with the launch likely to be slow and not a near-term source of financial upside,” Jefferies analysts wrote Monday morning, while forecasting the potential for $1 billion in peak sales.
Both of the two previous DORA launches have faced difficulties in gaining market share too. Merck’s Belsomra (suvorexant), released in 2014, required warning labels regarding next-day residual effects and abuse potential, among other safety risks. And Eisai’s Dayvigo (lemborexant) scored an FDA approval in Dec. 2019 and launched the next year but also required similar warnings.
Idorsia originally spun off from Swiss pharma company Actelion after a $30 billion acquisition by Johnson & Johnson in early 2017. Idorsia had been Actelion’s old R&D department and is headed up by Actelion’s founder and CEO, Jean-Paul Clozel.
Three other drugs currently in Idorsia’s pipeline have reached the Phase III stage.
Article updated to note that Dayvigo was approved in Dec. 2019, not Dec. 2020.