Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US Food and Drug Administration (FDA) for its plasma-derived therapy Hyqvia (human immunoglobulin 10%). The therapy is now approved for use as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). Initially approved in the US in 2014 for the treatment of primary immunodeficiency (PI), Hyqvia’s new indication expands its application in neuropathy management.
The announcement was made by local partner Halozyme Therapeutics (NASDAQ: HALO), which highlighted that Hyqvia stands as the only subcutaneous immunoglobulin (SCIG) infusion product in the country. This unique status is attributed to the inclusion of Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) in the formulation. Enhanze facilitates the dispersion and absorption of large volumes of immunoglobulin in the subcutaneous space, enabling self-administration and providing a convenient alternative to intravenous immunoglobulin therapies.- Flcube.com
