Clinical Trials

Takeda has announced data from the phase 3 ADVANCE-CIDP 3 trial, which assessed the safety and efficacy of Hyqvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) in patients with chronic inflammatory dymyelinating polyneuropathy (CIDP).

The results of this trial demonstrated positive long-term safety and tolerability of the drug, with alow relapse rate, which supports its use as a maintenance treatment for this indication. Full results were expected to be presented at a poster session at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada, on 22-25 June 2024. The trial demonstrated a median duration of Hyqvia treatment of 33 months with a cumulative overall follow-up time of 220 patient years. The findings were consistent with the known safety and tolerability profile of the drug and no new safety concerns were observed.

Kristina Allikmets, senior vice president and head of research and development for Takeda’s plasma-derived therapies business unit, commented: “The long-term data from the ADVANCE-CIDP 3 clinical trial allow us to further characterise 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. These results reflect our continued commitment to bringing the benefits of our differentiated immunoglobulin therapies to patients with neuroimmunological disorders, and providing a range of effective treatment options that address the individual needs of a broad range of patients.”

“Results of the ADVANCE-CIDP 3 study help provide additional confidence to those living with CIDP and their healthcare providers regarding the potential for extended maintenance of their condition with afacilitated subcutaneous immunoglobulin,” said Dr Robert Hadden MD, consultant neurologist, neurology department, King’s College Hospital and Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, both London, UK and ADVANCE-CIDP 3 presenting author. “This treatment allows the convenience of potential self-treatment at home, typically only once every four weeks.”