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Idorsia Receives Approval In Japan For Pivlaz To Treat Cerebral Vasospasm, Related Issues

Swiss pharma company Idorsia Ltd (IDRSF.OB) and its Japanese arm Idorsia Pharmaceuticals Japan, said on Thursday that the Pharmaceuticals and Medical Devices Agency or PMDA has approved Pivlaz (Clazosentan Sodium) 150 mg, based on a Phase 3 program in Japan.

Pivlaz is a 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).

Aneurysmal subarachnoid hemorrhage is a condition involving sudden life-threatening bleeding occurring in the subarachnoid space. It is caused by the rupture of an aneurysm - a weak, bulging spot on the wall of a cerebral artery.

aSAH is a major health issue in Japan, with an incidence at least twice as high as in many other countries of the world.

Pivlaz was evaluated in placebo-controlled, randomized, double-blind studies in adult Japanese patients post-aSAH treated by endovascular coiling or microsurgical clipping.

The drug was shown to reduce the occurrence of cerebral vasospasm-related morbidity and all-cause mortality within six weeks post-aSAH with statistical significance (p<0.01 for both studies).

The incidence of aSAH is estimated to be between six and nine per 100,000 per year worldwide. However, aSAH is a significant problem in Japan, with an incidence at least twice as high as in many other countries of the world.

The peak incidence in Japanese people occurs in adults in their 50s but can also occur in young people in their 20s and 30s.

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