Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan have announced that PIVLAZ (clazosentan) is now available to physicians in Japan to start treating aSAH patients. PIVLAZ is a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm.
PIVLAZ 150 mg, is indicated for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.
Aneurysmal subarachnoid hemorrhage (aSAH) is a sudden, life-threatening bleeding occurring in the subarachnoid space, caused by the rupture of an aneurysm. An urgent intervention involving endovascular coil embolization or microscopic clipping is required to stop bleeding and prevent rerupture. Clot hemolysis and the release of vasoconstricting agents can contribute to cerebral vasospasm, which typically begins approximately 3 days after aSAH onset, peaks in severity at days 8–11, and resolves by day 21. If untreated, cerebral vasospasm can be a key factor of morbidity and mortality in patients with aSAH. Cerebral vasospasm may lead to delayed ischemic neurological deficit (DIND) in 20-50% of aSAH patients, and half of the patients with severe vasospasm develop cerebral infarction. With an occurrence of 22.2 per 100,000 person-years, aSAH is 2–3 times more frequent in Japan than in the rest of the world and is therefore a significant problem in this country.
Satoshi Tanaka, Dr Med Sci. and President of Idorsia Pharmaceuticals Japan, commented:
“I am very proud to be launching Idorsia’s first product here in Japan, and I’m sure it will be the first of many innovative medicines from Idorsia, which will help many patients. I’m also proud of the Japanese team for bringing this important product to patients. The results with clazosentan are very impressive and represent a ground-breaking therapeutic advancement in the prevention of cerebral vasospasm. When listing PIVLAZ, the National Health Insurance system has recognized this innovative medicine as fulfilling an important medical need for patients facing a life-threatening condition. I know too that the expert physicians are very happy to finally have PIVLAZ for their patients, so that they can prevent the devastating consequences of cerebral vasospasm which occur even after the initial intervention has been successful. Together, we can change the lives of many Japanese patients.”
Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“It is very fitting that the first product to reach patients comes from the research our team has been working on for many years. Finally, our perseverance has paid off and our drug can now treat the patients suffering from this unpredictable and devastating condition. This milestone also represents a transformation for Idorsia as we can now deliver innovation from the lab bench to the patients’ bedside.”