Zai Lab has introduced an innovative treatment option for patients suffering from chronic inflammatory demyelinating polyneuropathy (CIDP) with the launch of efgartigimod alfa injection, delivered subcutaneously as efgartigimod SC.
Efgartigimod SC is an innovative subcutaneous treatment that combines efgartigimod alfa injection, originally marketed as VYVGART® for intravenous use, with recombinant human hyaluronidase PH20 (rHuPH20), a technology developed by Halozyme known as ENHANZE®. This combination utilises Halozyme's ENHANZE® drug delivery technology to enhance the subcutaneous administration of biologics.
Efgartigimod SC acts by binding to the neonatal Fc receptor (FcRn), which leads to a reduction in circulating IgG. Efgartigimod SC is the first and only FcRn blocker approved for subcutaneous injection.
In China, where the prevalence of CIDP is estimated to affect around 50,000 patients, the primary treatment options have traditionally been corticosteroids and intravenous immunoglobulin (IVIg). Plasma exchange (PLEX) is typically reserved for refractory cases. Unfortunately, access to PLEX or IVIg is limited in many regions, including China.
Most CIDP patients require ongoing treatment, there is a substantial unmet need for alternative treatment options that are effective, well-tolerated, and convenient for these patients in China and beyond.
The National Medical Products Administration's Centre for Drug Evaluation (CDE) has granted breakthrough therapy designation to efgartigimod alfa injection (subcutaneous) – efgartigimod SC for the management of chronic inflammatory demyelinating polyneuropathy (CIDP) in patients.