Zai Lab and Argenx Secure Chinese Approval for VYVGART Hytrulo in Treating CIDP

Zai Lab and Argenx Secure Chinese Approval for VYVGART Hytrulo in Treating CIDP

By, Admin 13 November 2024

Overview

Zai Lab and argenx have announced that China's National Medical Products Administration (NMPA) has approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (1,000mg, 5.6ml per vial).

The ENHANZE® Drug Delivery Technology

  • VYVGART Hytrulo uses Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous delivery, allowing either healthcare professionals or trained patients and caregivers to administer the treatment at home. 
  • Approved for generalised myasthenia gravis (gMG) and CIDP in the United States, Europe, Japan, and China, the therapy aligns with global standards for IgG-mediated autoimmune conditions.

Post Approval

This approval enables the use of Efgartigimod Alfa (Subcutaneous Injection) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as the first authorised treatment for the condition in China. 

The New Therapeutic Option

VYVGART Hytrulo offers a new therapeutic option with a weekly 30-to-90 second subcutaneous injection, providing significant convenience for CIDP patients, who are affected by a progressive, immune-mediated neuromuscular disorder impacting the peripheral nervous system.

Behind the Approval

The approval was based on data from the ADHERE study (NCT04281472), a multicenter, double-blind, placebo-controlled clinical trial evaluating the efficacy of VYVGART Hytrulo in CIDP. 

Outcomes in VHnese Patients

  • Participants in China displayed consistent outcomes with the global cohort, showing a 69% reduction in relapse risk compared to the placebo group.
  • In the study's open-label phase, 78% of Chinese patients demonstrated clinical improvement, highlighting the therapy's potential to reduce symptoms and improve stability in CIDP cases. 

The treatment’s safety and tolerability profile in Chinese patients were similar to those seen in global trial participants.

CDE Priority Review 

  • This approval follows the Centre for Drug Evaluation's (CDE) priority review of the sBLA in May 2024, recognising the treatment as a Breakthrough Therapy for CIDP patients in September 2023. 
  • The approval underscores VYVGART Hytrulo’s differentiated profile, addressing a previously unmet medical need in China, where around 50,000 patients are diagnosed with CIDP.

Zai Lab holds exclusive rights to develop and commercialise efgartigimod in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.