TOKYO (dpa-AFX) - Japan's Takeda Pharmaceutical Co. Ltd. (TAK, TKPHF.PK) announced Tuesday that the U.S. Food and Drug Administration has approved a supplemental biologics license application or sBLA to expand the use of HYQVIA to treat primary immunodeficiency or PI in children 2-16 years old.
HYQVIA is the only subcutaneous immune globulin or ScIG infusion that can be administered once a month - every three or four weeks. It was first approved in the U.S. in 2014 for the treatment of PI in adults.
PI is an umbrella term to describe a group of more than 400 disorders that affect the body's immune system, increasing susceptibility to infection.
The company noted that the FDA approval of HYQVIA to treat PI in pediatric patients was based on evidence from a pivotal, prospective, open-label, non-controlled Phase 3 clinical trial.
The data from 44 PI patients between the ages of 2 and 16 showed no clinically meaningful differences in trough Immunoglobulin G (IgG) levels across age groups. During the 12-month trial period, HYQVIA was shown to be efficacious with respect to the occurrence of acute serious bacterial infections (aSBIs), a primary endpoint.
Brandon Monk, head of Takeda's U.S. Plasma-Derived Therapies Business Unit, 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.'
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