Zai Lab Secures Breakthrough Therapy Designation for Efgartigimod Alfa Injection in CIDP Patients
Zai Lab Limited has recently secured Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for their efgartigimod alfa injection, intended to treat chronic inflammatory demyelinating polyneuropathy (CIDP). This prestigious designation was granted based on data from the ADHERE study, which included both global and Chinese patients.
The Breakthrough Therapy Designation expedites the development and review process for novel medications intended to treat severe, life-threatening diseases or conditions that significantly impact patients' quality of life when there are no existing treatment options or when the new drug offers clear advantages over current therapies.
Efgartigimod alfa injection (subcutaneous injection) is proposed to be known by this name in China. In the United States, it is marketed as VYVGART Hytrulo, and it may receive different names in other regions following approval.
This medication represents a subcutaneous combination of efgartigimod alfa injection, a human IgG1 antibody fragment (marketed as VYVGART®), and recombinant human hyaluronidase PH20 (utilizing Halozyme’s ENHANZE® drug delivery technology).It operates by binding to the neonatal Fc receptor (FcRn), ultimately reducing circulating IgG levels. Notably, it is the first and only approved FcRn blocker administered via subcutaneous injection.
