The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502) for its plasma-derived therapy Hyqvia (human immune globulin infusion 10% with recombinant human hyaluronidase) as a maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). This follows a similar indication extension for the subcutaneous drug in the U.S. earlier this month. Concurrently, its intravenous counterpart, Gammagard Liquid (human immune globulin), received approval as an induction therapy for the immune-mediated condition in the U.S. market.
The EC’s decision was informed by a Phase III study demonstrating that Hyqvia significantly reduced the CIDP relapse rate to 15.5% from 31.7% in the placebo group, with fewer severe and serious adverse events reported in the treatment arm.
The announcement was made in conjunction with partner Halozyme Therapeutics (NASDAQ: HALO), which highlighted that Hyqvia is now the only subcutaneous immunoglobulin (SCIG) infusion available in the region. This distinction is attributed to the inclusion of Halozyme’s proprietary enzyme Enhanze (rHuPH20) in the formulation, enabling self-administration and promoting the efficient dispersion and absorption of large immunoglobulin volumes in the subcutaneous space.-Fineline Info & Tech
