Sosei Group Reports MFDS’ Approval of Pivlaz (clazosentan sodium) for Aneurysmal Subarachnoid Hemorrhage (aSAH)
Shots:
- The company has secured the marketing authorisation of Pivlaz (150mg) from the MFDS for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH)
- The approval relies on data from the Japanese P-III program of Pivlaz in patients with aSAH who underwent clipping or coiling, depicting reduction in cerebral vasospasm-related complications and all-cause mortality within 6wks. of aSAH. The studies also validated the safety profile
- Pivlaz’s marketing authorization is held by Idorsia Pharmaceuticals Korea (IPK) in South Korea & will be accessible to patients from early 2025
Ref: Sosei | Image: Sosei
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
