FDA approves Hyqvia for chronic inflammatory demyelinating polyneuropathy

The FDA has approved Takeda Pharmaceutical’s Hyqvia, coformulated with Halozyme's Enhanze drug delivery technology, to treat chronic inflammatory demyelinating polyneuropathy in adults.

According to a Takeda press release, Hyqvia is the only currently available FDA-approved combination of immunoglobulin (IG) and hyaluronidase for adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

Hyqvia’s subcutaneous route of delivery allows it to be administered by a health care professional in the office, at an infusion center or at home, or self-administered after appropriate training, according to the release. The Enhanze technology facilitates the dispersion and absorption of large subcutaneous IG volumes, allowing for administration every 2, 3 or 4 weeks, according to a press release from Halozyme.

Hyqvia was initially approved by the FDA in 2014 to address primary immunodeficiency in adults, and the approval has since been expanded to include young persons from 2 to 16 years old, according to the Takeda release.

“With the FDA approval of Hyqvia for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalized maintenance treatment option for adults with this debilitating disease,” Giles Platford, president of Takeda’s plasma-derived therapies business unit, said in the release.

Reference:

Halozyme announces Takeda receives FDA approval for Hyqvia co-formulated with Enhanze as maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). https://ir.halozyme.com/news/news-details/2024/Halozyme-Announces-Takeda-Receives-FDA-Approval-for-HYQVIA-Co-formulated-with-ENHANZE-as-Maintenance-Therapy-in-Adults-with-Chronic-Inflammatory-Demyelinating-Polyneuropathy-CIDP/default.aspx. Posted Jan. 16, 2024. Accessed Jan. 16, 2024.