Monday, Takeda Pharmaceutical Company Limited (TAK) announced positive topline data from TAK-881-3001, a pivotal Phase 2/3 clinical trial evaluating TAK-881 in patients with Primary Immunodeficiency Disease or PID.
The trial evaluated the pharmacokinetic, efficacy, safety, tolerability and immunogenicity of TAK-881 in adults and pediatric patients aged 2 years and older with PID previously treated with IG therapy and compared them with HYQVIA in patients aged 16 years and older.
The study met its primary endpoint, showing equivalent immunoglobulin G exposure between TAK-881 and HYQVIA. It also demonstrated comparable infection rates and immune protection to HYQVIA, with protective IgG levels consistently maintained throughout the study.
Supported by this positive data, the company expects to submit applications for TAK-881 to regulatory authorities in the United States, European Union and Japan in fiscal year 2026.
"These topline results from TAK-881-3001 are encouraging. They show that a highly concentrated, hyaluronidase-facilitated subcutaneous IG can provide immune protection with a more manageable infusion experience intended to enhance the day-to-day lives of patients living with PID," said Richard Wasserman, allergist/immunologist and principal investigator for TAK-881-3001.
In the pre-market hours, TAK is trading at $16.76, up 0.81 percent on the New York Stock Exchange.
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