Idorsia receives PMDA (Japan) approval of Pivlaz (clazosentan sodium) 150 mg to treat cerebral vasospasm.

The PMDA approval of Pivlaz is based on a dedicated Japanese Phase III program.

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. Emergency procedure (endovascular coiling or microsurgical clipping) is required to stop the hemorrhage. The bleeding and the release of endothelin, a potent vasoconstrictor produced by the neighboring vascular endothelium, can lead to cerebral vasospasm (constriction of arteries in the brain), usually occurring between 4 and 14 days after aneurysm securing. This diminishes blood flow to the brain, and about one third of patients consequently experience worsening of their neurological condition. Cerebral vasospasm is one of the leading secondary causes of disability and death in patients with aSAH.

The incidence of aSAH is estimated to be between 6 and 9 per 100,000 per year worldwide. Notably, 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.