FDA approves Hyqvia for children with primary immunodeficiency
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Key takeaways:
- The FDA approval makes Hyqvia available for children aged 2 to 16 years with primary immunodeficiency.
- The subcutaneous immune globulin infusion can be administered every 3 to 4 weeks.
The FDA has approved a supplemental biologics license application for the use of Hyqvia to treat primary immunodeficiency in children aged 2 to 16 years, according to a press release from Takeda.
First approved for treating adults with primary immunodeficiency (PI) in the United States in 2014, Hyqvia (Ig infusion 10% [Human] with recombinant human hyaluronidase) is the only subcutaneous immune globulin infusion that can be administered every 3 or 4 weeks, according to the press release.
The FDA based its approval on the results of a prospective, open-label, non-controlled phase 3 clinical trial of 44 patients with PI aged 2 to 16 years. After a year of observation, there were no clinically meaningful differences in trough IgG levels across age groups.
Also, Takeda called Hyqvia effective in terms of acute serious bacterial infections, with a mean rate of 0.04, in addition to all infections, with a mean rate of 3.2 per subject year.
The treatment’s safety profile resembled profiles observed among adult patients as well, according to the press release.
“Families of children living with primary immunodeficiency may feel overwhelmed by their child’s chronic medical needs,” Jorey Berry, president and CEO of the Immune Deficiency Foundation, said in the press release. “When it comes to treatment, having choices can mean a great deal to families.”
According to the press release, IG infusions can be effective in protecting children from infections associated with PI diagnoses, but some therapy options may not be optimal for them and their families. Some children may find intravenous administration difficult, the release continued, while the frequency of other subcutaneous therapies may be challenging.
“This expanded Hyqvia indication exemplifies our ongoing commitment to providing plasma-derived therapies with proven efficacy,” Brandon Monk, MBA, senior vice president of the Takeda U.S. Plasma-Derived Therapies Business Unit, said in the press release.