Idorsia Pharmaceuticals Submits NDA to PMDA for Daridorexant to Treat Insomnia
Shots:
- The NDA submission was backed by the results from the P-III study evaluating the safety & efficacy of daridorexant (25 & 50mg) vs PBO in patients with insomnia across Japan. Following the NDA submission Sosei Heptares will receive ~$10M as milestone payments
- The results depicted that the study met both the 1EPs & 2EPs with 1EPs incl. an improved sTST & decreased sLSO vs PBO at 28days
- Idorsia (a subsidiary of Sosei) has jointly developed Daridorexant (ACT-541468), a dual orexin receptor antagonist, with Mochida Pharmaceutical. Additionally, Daridorexant has already been approved in the US & EU and is marketed in both regions by Idorsia as Quviviq
Ref: Idorsia | Image: Idorsia
Related News:- Idorsia’s Quviviq (daridorexant) Receives NICE Recommendation for Adults with Chronic Insomnia
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
