Takeda’s Gammagard Liquid approved by FDA for new indication

Takeda announced that the U.S. Food and Drug Administration has approved Gammagard Liquid as an intravenous immunoglobulin therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy, or CIDP. It can be used as induction therapy, which includes an induction dose followed by maintenance doses. For treatment of CIDP, Gammagard Liquid has not been studied in immunoglobulin-naive patients nor as maintenance therapy for periods longer than six months. “The approval of Gammagard Liquid for treatment of CIDP is an encouraging validation of our decades-long commitment to advancing plasma-derived therapies on behalf of people living with rare neuromuscular disorders and bringing our portfolio of differentiated IG therapies to these patients. Together with the recent Hyqvia approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs,” said Richard Ascroft, senior vice president and head of Takeda’s U.S. Plasma-Derived Therapies Business Unit.