The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.
Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.
The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.
Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.