TOKYO (dpa-AFX) - Takeda Pharmaceutical Co. Ltd. (TAK) announced Tuesday
favorable long-term data from the Phase 3 ADVANCE-CIDP 3 clinical trial of
HYQVIA in Patients with Chronic Inflammatory Demyelinating Polyneuropathy or
CIDP.

CIDP is an acquired, immune-mediated condition affecting the peripheral nervous
system that is characterized by progressive, symmetric weakness in distal and
proximal limbs and impaired sensory function in the extremities.

The long-term extension study evaluates the safety and efficacy of HYQVIA
(Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase) in
patients with CIDP. The ADVANCE-CIDP 3 clinical trial is the longest extension
study ever performed within context of a clinical trial in CIDP to date, the
company noted.

The results showed favorable long-term safety and tolerability of HYQVIA, and a
low relapse rate, supporting its use as maintenance treatment for CIDP.

The company plans to present these findings in a poster session on June 23, 2024
at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada.

HYQVIA is the first and only facilitated subcutaneous immunoglobulin (fSCIG) for
CIDP, approved earlier this year by the U.S. Food and Drug Association as
maintenance therapy in adults with CIDP and by the European Commission for
patients of all ages with CIDP post-stabilization with intravenous
immunoglobulin (IVIG).

Kristina Allikmets, senior vice president and head of Research & Development for
Takeda's Plasma-Derived Therapies Business Unit, said, 'The long-term data from
the ADVANCE-CIDP 3 clinical trial allow us to further characterize the safety,
efficacy and tolerability profile of HYQVIA and reinforces its role as a
long-term, up-to once monthly maintenance treatment for this complex, chronic
condition.'

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