Sosei Announces Submission of New Drug Application in Japan for Daridorexant
ALLSCHWIL, Switzerland and RADNOR, Pa., July 10, 2023 /PRNewswire/ -- Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals US Inc. today announced that, effective immediately, CVS is covering QUVIVIQ® (daridorexant) CIV on the Performance Drug List (PDL). Approximately 20 million people are enrolled in this CVS plan, providing increased access to QUVIVIQ for the millions of adults who can benefit from this latest prescription insomnia therapy. QUVIVIQ is now covered by two of the largest insurance plans in the US, Express Scripts and CVS, and several associated regional plans, as well as TRICARE, the healthcare program for active and retired US military personnel and their families.
QUVIVIQ„¢ is indicated for the treatment of adult patients with insomnia, characterized by symptoms present for at least three months and considerable impact on daytime functioningQUVIVIQ,...
Swiss biopharma Idorsia gave out few details Tuesday about a potential $440.8 million (400 million CHF) deal with an unnamed company that would include licensing rights to some of Idorsia’s products in the Asia-Pacific region, excluding China.
RADNOR, Pa., May 10, 2023 /PRNewswire/ -- Idorsia Pharmaceuticals US Inc. announced today its support of a clinical study sponsored by the U.S. Department of Defense (DOD) to develop new therapies to treat Posttraumatic Stress Disorder (PTSD). The Phase 2 multi-center, multi-arm, randomized, placebo-controlled, double-blind, adaptive platform clinical trial will evaluate the safety, tolerability, and efficacy of potential therapeutic interventions in active-duty U.S. service members and veterans with PTSD. This clinical trial will include QUVIVIQ® (daridorexant) CIV, a medicine approved by the FDA for the treatment of adults with difficulty falling or staying asleep (insomnia), and at least two other FDA-approved medications for the treatment of depression, all of which will be studied under an Investigational New Drug application for the treatment of PTSD. QUVIVIQ is a dual orexin receptor antagonist (DORA) that was approved in 2022 in the United States and the European Union, and it is the only FDA-approved insomnia medication being evaluated in this study.
The DOD will sponsor a phase 2 study of Idorsia’s Quviviq and two antidepressant drugs, measuring their effectiveness in patients with PTSD.
QUVIVIQ is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.Idorsia Canada – led by General Manager Ron Morcos –...
Classified as a Schedule IV controlled substance, Idorisia’s potentially game-changing insomnia treatment Quviviq is under tight control by the Drug Enforcement Agency (DEA), just like virtually every other medication for the condition. nnBut Idorsia—a Swiss spinout of Johnson & Johnson subsidiary Actelion—is anxious to get rid of its “controlled substance” label, filing (PDF) a Citizen Petition (CP) with the agency this week. nnIdorsia is not only angling to clear Quviviq from the Schedule IV list, the petition requests de-scheduling for all drugs in its dual orexin receptor (DORA) class. nnQuviviq, which was approved in January of last year. is the third DORA on the market for insomnia—after Merck’s Belsomra and Eisai’s Dayvigo—but is considered the only one with blockbuster potential because of its unique ability to both induce sleep and keep patients alert during the day. nnIn its petition, Idorsia cites eight years of post-marketing surveillance data which provides evidence that the DORA class has negligible potential to be abused. Idorsia points to the lack physical and psychological dependence from DORA drugs and no evidence of non-medical use of them. nn“We are a completely different drug, without this risk,” Idorsia CEO Jean-Paul Clozel said in an interview. “This scheduling should be taken away.”
New drug approvals were fewer in number in 2022. Is this a trend that will continue into 2023 or is the drop off just a cyclical anomaly?
Board of Directors Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that at its December meeting, the Board of Directors of Roche Holding Ltd has approved to propose the...