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Idorsia scores FDA go-ahead for insomnia drug Quviviq to rival Merck’s Belsomra, Eisai’s Dayvigo

The FDA blessed Idorsia’s Quviviq (daridorexant), a sleeping pill for those with insomnia. Because the FDA has recommended Idorsia to register Quviviq as a controlled substance, the treatment will not reach the market until May, the company said.

After more than two decades of trial and error and experiments with—by their estimate—25,000 compounds, the husband and wife team of executives at Idorsia, Jean-Paul and Martine Clozel, said they have finally reached the finish line with a drug they believe can be a game-changer.

With 25 million Americans affected by insomnia and only about 30% of them diagnosed, a huge untapped market awaits. But Idorsia has a big task ahead to distinguish Quviviq from Merck’s Belsomra, which has been on the market for seven years, uses the same mechanism and has not had the most successful market.

Quviviq is the first approval for Switzerland-based Idorsia, a company the Clozels established in 2017 after they sold Actelion to Johnson & Johnson for $30 billion.

In two phase 3 studies, Quviviq showed significant improvement over placebo in sleep onset, sleep maintenance and total sleep time, while also reducing daytime sleepiness.

Both Quviviq and Merck’s Belsomra are from the dual orexin receptor antagonist (DORA) class. Belsomra has had difficulty catching on, generating sales of $327 million in 2020. Another DORA, Eisai’s Dayvigo, was launched in 2020.

The difference between Quviviq and the other DORAs, according to Idorsia, is that it keeps people energetic and awake throughout the day. Belsomra’s development was hindered by warnings about next-day somnolence and depression, forcing Merck to cut its dosage to suboptimal levels to gain approval.

Finding a treatment that strikes the delicate balance between providing nighttime restfulness and daytime functioning is why it took so long to develop Quviviq, Martine Clozel, executive vice president and chief scientific officer, said in an interview.

“It really took us many years to arrive [at] a compound with the right duration of action,” Clozel explained.

For decades, insomnia has been treated with sedatives, such as Ambien. The generic versions of these treatments still dominate the market, though they can cause memory problems and morning sedation.

Roughly 20 years ago, scientists found it was the orexin system that keeps the brain awake. This discovery kicked off a new way of targeting insomnia. Quviviq and other DORAs block the binding of the wake-promoting neuropeptides orexins, tuning down overactive wakefulness, as opposed to sedating the brain.

At Actelion, the Clozels developed an insomnia treatment, almorexant, but had to bail on it in 2011 because of safety concerns. After licensing the drug to Midnight Pharma, Actelion got to work on another insomnia treatment.

Ten years later, the Clozels believe they’ve finally got it right. “We believe we’ve hit the jackpot with regard to the dose response” Patty Torr, president and GM of Idorsia U.S., said in an interview, also pointing to the fact that Quviviq is not a brain-sedating-type medicine. The drug will be available in 50 mg and 25 mg doses.

Getting patients to believe in this DORA will require a major marketing effort, which the company has already begun with an awareness program, Alliance for Sleep. Another effort underway is the Seize the Night campaign which will specifically touts combination of daytime and nighttime benefits provided by Quviviq.

The unmet need in insomnia is undeniable. Many are diagnosed but do not seek treatment. Additionally, of those who are prescribed medicine, 25% drop out of the market annually, Torr said.

“There’s this churn going on in the marketplace,” she said.

And that spells opportunity for Idorsia.