Handok announced on December 7, 2023, that Pivlaz, a new drug for the prevention of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage, has been approved by the Korean Ministry of Food and Drug Safety (MFDS). The marketing authorization for Pivlaz is held by Idorsia Pharmaceuticals Korea (IPK), with whom Handok has been conducting joint domestic clinical trials and carrying out work associated with marketing authorization since 2008.

Pivlaz (component: clazosentan) is a selective endothelin A receptor antagonist indicated for the prevention of cerebral vasospasm and cerebral ischemic events associated with cerebral vasospasm in adults who have undergone craniotomy or coiling for aneurysmal subarachnoid hemorrhage. Pivlaz is the first drug approved in Korea to prevent both cerebral vasospasm and its complications.

Aneurysmal subarachnoid hemorrhage is a serious and urgent life-threatening condition characterized by bleeding in the subarachnoid space. At least 25% of patients with this condition die and approximately 50% of survivors have neurological deficits. It reportedly affects 6.7 people per 100,000 per year worldwide and 9 people per 100,000 per year in Korea. Cerebral vasospasm, which occurs after aneurysmal subarachnoid hemorrhage, is a major complication that requires active prevention and treatment. It doubles the risk of death in patients treated for subarachnoid hemorrhage and can result in symptoms such as focal paralysis, speech impairment, and decreased consciousness. Cerebral vasospasm is more likely to occur in people over the age of 65, but is more severe in younger patients.

The approval of Pivlaz was based primarily on two Phase 3 clinical trials conducted in Japan. The multicenter, double-blind, randomized, placebo-controlled Phase 3 study in patients who underwent clipping or coiling procedures after aneurysmal subarachnoid hemorrhage showed that Pivlaz significantly reduced the incidence of cerebral vasospasm-related complications and all-cause mortality within six weeks of subarachnoid hemorrhage. The study also confirmed its safety profile. Pivlaz was licensed in Japan in 2022, ahead of Korea, and is currently being administered there. A joint Korean-Japanese Phase 2 clinical study included 74 Korean patients and confirmed efficacy and tolerability in Japanese and Korean patients.

“Cerebral vasospasm after subarachnoid hemorrhage is a serious and potentially fatal condition, but the lack of medication has caused great difficulties in the medical field,” said Dr. Park Ik-seong, President of the Korean Society of Cerebrovascular Surgeons (Professor of Neurosurgery at St. Mary’s Hospital in Bucheon). “Now that Pivlaz, a drug that can prevent symptoms before they occur, has been approved in Korea, we hope that it will be covered by insurance as soon as possible for the sake of patients.”

Pivlaz is IPK’s first new drug to be licensed in Korea. IPK is committed to providing new treatment options for healthcare providers and patients in a variety of therapeutic areas.