Takeda picks up 2nd FDA-approved indication for immune globulin treatment HyQvia

It was a decade and four companies ago that HyQvia was first approved by the FDA for primary immunodeficiency (PI).

Ten years later, Takeda’s subcutaneous immune globulin treatment has scored its second indication, as the FDA has approved it as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). A progressive neurological disorder, CIDP causes weakness and reduced feeling in the arms and legs.

In 2014, when it was owned by Baxter, HyQvia was endorsed to treat adults with PI, an umbrella term referring to 400-plus rare diseases that can affect the immune system. Then in April of last year, Takeda won a label expansion to treat children ages 2 to 16.

The approval for CIDP was based on a phase 3 trial that enrolled 122 adults. The study showed that 14% of those on HyQvia relapsed, compared with 32% of those on placebo. Another phase 3 trial assessed the safety of the treatment in those who did not relapse in the previous trial.  

HyQvia can be infused every two, three or four weeks. With training, patients or caregivers can administer the drug at home.

The therapy represents a new option for CIDP, which has traditionally been treated with intravenous immunoglobulin (IVIG) infusions.

“While it is considered the standard-of-care for maintenance treatment of adults with CIDP, IVIG infusions may be challenging for some patients and their caregivers,” Lisa Butler, executive director, GBS-CIDP Foundation International, said in a release. “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.”

In December, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of HyQvia for maintenance with CIDP after stabilization with IVIG.

Takeda gained HyQvia when it acquired Shire in 2018. That move came two years after Shire bought Baxter's Baxalta spinoff.