- QUVIVIQ™ (daridorexant) – 25 and 50 mg – approved by the
US FDA for the treatment of adults with insomnia after demonstrating an improvement on objective measures of sleep onset and sleep maintenance, as well as an improvement in patient reported total sleep time
Allschwil,
Jean-Paul will describe the progress
“The first approval of QUVIVIQ is a pivotal moment for both
Highlights to look for in 2022
- QUVIVIQ (daridorexant) approved by the
US FDA for the treatment of adults with insomnia - Upcoming publication of daridorexant Phase 3 clinical trials in a peer-reviewed journal
- Conclusion of the review for clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) with the Japanese PMDA and subsequent launch, subject to approval
- Conclusion of the review for QUVIVIQ (daridorexant) for the treatment of insomnia with other health authorities
- Commercial launch of QUVIVIQ (daridorexant) in the US, following scheduling by the
US Drug Enforcement Administration - Results of PRECISION, the Phase 3 registration study with aprocitentan for difficult-to-control hypertension
- Results of the proof-of-concept study with our selective orexin 1 receptor antagonist in binge eating disorder
- First European launches of QUVIVIQ (daridorexant), subject to approval
- Initiation of the Phase 3 study with cenerimod for the treatment of SLE
- Conclusion of REACT the Phase 3 registration study with clazosentan
Jean-Paul commented on the outlook for 2022:
“This is the start of a transformative year for
Jean-Paul concluded:
“We will achieve all this whilst continuing to expand our product portfolio, which will be key for our future growth trajectory.”
Notes to the editor
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www.idorsia.com
The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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