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Idorsia Pharmaceuticals Ltd: Idorsia submits NDA for clazosentan to Japanese PMDA


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 ons ....

Switzerland General , Andrewc Weiss , Satoshi Tanaka , Idorsia Ltd , Head Of Investor Relations Corporate Communications , Swiss Exchange , Japanese Pharmaceuticals , Idorsia Pharmaceuticals Ltd , Life Sciences , Idorsia Pharmaceuticals Japan , Devices Agency , New Drug Application , Medical Devices Agency , Cerebrovascular Diseases , Pharmacol Exp Ther , Pharmaceuticals Japan , Vice President , Investor Relations , Pharmaceuticals Ltd , சுவிட்சர்லாந்து ஜநரல் , சதோஷி தனகா , தலை ஆஃப் முதலீட்டாளர் உறவுகள் பெருநிறுவன தகவல்தொடர்புகள் , சுவிஸ் பரிமாற்றம் , ஜப்பானிய மருந்துகள் , வாழ்க்கை அறிவியல் , புதியது மருந்து விண்ணப்பம் ,