Japan approves Pivlaz for aSAH vasospasm

PMDA approves Pivlaz to prevent cerebral vasospasm after aSAH

Iorsia Ltd and Idorsia Pharmaceuticals Japan announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved Pivlaz (clazosentan sodium) 150 mg, 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).

The PMDA approval of Pivlaz is based on a dedicated Japanese phase 3 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. 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 neurologic 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. The peak incidence in Japanese people occurs in adults in their 50s but can also occur in young people in their 20s and 30s.

What is Pivlaz (clazosentan sodium) approved for in Japan?

Pivlaz is approved by the PMDA for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms following aneurysmal subarachnoid hemorrhage (aSAH).

What is the mechanism of action of clazosentan sodium?

Clazosentan sodium is a selective endothelin A (ETA) receptor antagonist that helps prevent vasospasm caused by endothelin release after aSAH.

What clinical data supported the PMDA approval of Pivlaz?

The approval was based on a dedicated Japanese phase 3 program.

Why is cerebral vasospasm a concern after aSAH?

Cerebral vasospasm reduces blood flow to the brain and affects about one-third of patients, leading to worsening neurologic condition, disability, or death.

How prevalent is aneurysmal subarachnoid hemorrhage in Japan?

Japan has at least twice the incidence of aSAH compared with many other countries, with peak cases occurring in adults in their 50s and also affecting younger individuals.