The US Food and Drug Administration (FDA) has approved Takeda’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years.
HyQvia is a liquid medicine containing recombinant human hyaluronidase and immunoglobulins (Ig). It was previously approved in the US to treat PI in adults.
The drug is claimed to be the only ScIG infusion that can be given once a month.
Takeda US Plasma-Derived Therapies Business Unit head Brandon Monk said: “This expanded HyQvia indication exemplifies our ongoing commitment to providing plasma-derived therapies with proven efficacy.
“HyQvia is now available to a broader community impacted by PI, including children and their families with distinct needs, who may prefer flexible treatment options in the management of these disorders.”
The expanded regulatory approval was based on the data obtained from an open-label, pivotal, non-controlled, prospective Phase III clinical trial conducted in 44 PI patients aged between two years and 16 years.
HyQvia was found to be effective as a treatment for acute serious bacterial infections. This was a primary endpoint of the trial.
The trial continued for 12 months, and the medicine’s efficacy was further shown by the overall rate of infections per participant.
Takeda noted that the findings from the interim data analysis indicated similar safety profiles to those of adults. There were no clinically meaningful differences in trough immunoglobulin G (IgG) levels across the age groups.
HyQvia is also approved in the European Union (EU) as a replacement therapy in patents of all age groups with PI and secondary immunodeficiency.
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