Idorsia gains Japanese PMDA approval of Pivlaz

The Japanese subsidiary of Swiss biotech Idorsia (SIX: IDIA) today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved Pivlaz (clazosentan sodium) 150mg. The firm’s shares gained 3.6% to 21.84 Swiss francs in early trading.

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

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.