'Pivlaz Inj' makes another attempt to be reimb in KOR

Distributed by Handok

New drug for the prevention of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage…received marketing authorization in December 2023

The company withdrew the reimbursement application in June 2024…it is making another attempt at reimbursement after strengthening the document

'Pivlaz Inj,' which is supplied·distributed in South Korea by Handok, has been submitted for another attempt at reimbursement.

 

The marketing authorization for Pivlaz was approved in South Korea in December 2023.

 

Then, the company applied for reimbursement but voluntarily withdrew the reimbursement application in June 2024.

 

According to industry sources on January 2, the reimbursement application for Pivlaz Inj (clazosentan disodium) was submitted to the Health Insurance Review and Assessment Service (HIRA).

 

Pivlaz Inj, a selective endothelin receptor antagonist, received Korean marketing authorization on December 7, 2023, for the indication to prevent cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms in adults who had undergone clipping or coiling treatment for aneurysmal subarachnoid hemorrhage.

 

Cerebral vasospasm after aneurysmal subarachnoid hemorrhage increases the risk of death in patients by twofold.

 

Prevention and treatment are crucial because they accompany serious complications, such as local paralysis, language impairment, and decreased cognition.

 

However, treatment for the disease has been difficult because there has been no medication available for it.

 

In Phase 3 clinical trial (AC-054-305), involving patients who had undergone coiling treatment for aneurysmal subarachnoid hemorrhage, Pivlaz showed a statistically significant reduction in the percentage of mortality due to delayed ischemic neurologic deficit or all-cause associated with cerebral vasospasm in the 10mg/h treatment.

 

The percentage for the placebo group was 28.8% (32/111 cases), and that of the 10mg/h treatment group was 13.6% (14/103 cases).

 

Before the approval in South Korea, the Central Pharmaceutical Affairs Advisory Committee (CPAC) determined that the drug's concurrent use with nimodipine lacked a basis for the drug's benefit and, unlike in Japan, a trial result comparing the drug to nimodipine, which is a standard therapy in South Korea, is needed.

 

However, during reconsideration by the CPAC, a comprehensive result from an additionally submitted document demonstrating a comparison with nimodipine and the company's plan to secure documents in Korean was evaluated.

 

The CPAC has concluded that clazosentan monotherapy (excluding its concurrent use with nimodipine) will be approved based on Japan's Phase 3 clinical trial results.

 

The company applied to HIRA for reimbursement after obtaining approval.

 

However, it withdrew the approval in June.

 

Recently, it was reported that the company attempted reimbursement again with strengthened documents.

 

Nxera Pharma Korea obtained the domestic approval for Pivlaz.

 

Nxera Pharma Korea is a Japanese multinational company that acquired the Pivlaz developer, Swedish pharmaceutical company Idorsia Pharmaceuticals.

 

In April 2024, the company changed its name from Sosei Group to Nxera Pharma.

 

On April 12, 2024, Handok signed an agreement with Nxera Pharma Korea for the domestic supply and marketing of 'Pivlaz.' Handok plans to launch Pivlaz this year.

 

To achieve this goal, the company must pass the reimbursement review.

 

It draws attention to whether Handok, which has been focusing on strengthening new drug competitiveness in the rare diseases field, will achieve business goals by potentially obtaining reimbursement for Pivlaz.