Investegate announcements from Idorsia Pharmaceuticals Ltd, The Journal of Neurosurgery reports impact of clazosentan on cerebral vasospasm-related morbidity and all-cause mortality after aneurysmal subarachnoid hemorrhage
Ad hoc announcement pursuant to Art. 53 LR Idorsia receives Japanese PMDA approval of PIVLAZ (clazosentan sodium) 150 mg Allschwil, Switzerland - January 20, 2022Idorsia Ltd (SIX: IDIA) and
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Idorsia submits NDA for clazosentan to Japanese PMDA
Idorsia Pharmaceuticals LtdMarch 1, 2021 GMT
Allschwil, Switzerland – March 1, 2021
Idorsia Ltd (SIX: IDIA) today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ETA) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).
The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH. Patients were randomized to receiv
Idorsia Pharmaceuticals Ltd: Idorsia submits NDA for clazosentan to Japanese PMDA
Allschwil, Switzerland - March 1, 2021
Idorsia Ltd (SIX: IDIA) today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ET
A) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).
The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH. Patients were randomized to receive continuous infusion of either 10 mg/hr clazosentan or placebo for up to 15 days following the onset of aSAH. The