Takeda shares long-term results for HyQvia in CIDP

Takeda has unveiled the long-term data from a phase 3 study examining the safety and efficacy of HyQvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). HyQvia, a unique immune globulin infusion (10% human) combined with recombinant human hyaluronidase, gained regulatory approvals earlier this year to treat the rare neurological disorder, which is marked by progressive weakness and decreased sensation in the arms and legs.

This treatment stands out as the first and only facilitated subcutaneous immunoglobulin therapy for CIDP, enabling self-administration following appropriate training of the patient or caregiver. Healthcare professionals can also administer it in medical settings or at the patient’s home. The ADVANCE-CIDP 3 study, which was conducted at a late stage, showed that HyQvia was well tolerated across more than 3,400 infusions. The findings aligned with the known safety and tolerability profile of the therapy, with no new safety concerns emerging.

In terms of efficacy, HyQvia demonstrated its ability to maintain a stable disease course, with only 13% of participants experiencing a relapse over the observation period, leading to an annualized relapse rate of 4.5%. Kristina Allikmets, senior vice president and head of research and development for Takeda’s plasma-derived therapies business unit, stated that the long-term data from the ADVANCE-CIDP 3 trial helps to further define the safety, efficacy, and tolerability profile of HyQvia. She emphasized that these findings solidify HyQvia’s role as a long-term, up-to-once-monthly maintenance treatment for this intricate, chronic condition.

Regulatory bodies have recognized the value of HyQvia. The European Commission and the Medicines and Healthcare products Regulatory Agency have approved it as a maintenance therapy for CIDP patients of all ages following stabilization with intravenous immunoglobulin therapy. Additionally, the US Food and Drug Administration has granted approval for HyQvia as a maintenance therapy to prevent relapses of neuromuscular disability and impairment in adults with CIDP.

Robert Hadden, the presenting author of the ADVANCE-CIDP 3 study and affiliated with King’s College Hospital and King’s College London, remarked that the study’s results offer additional confidence to CIDP patients and their healthcare providers. He noted that the data demonstrate the potential for extended maintenance of the condition with facilitated subcutaneous immunoglobulin therapy.

In summary, Takeda's HyQvia has shown promising long-term results in the treatment of CIDP, with regulatory approvals backing its use across various regions. The therapy’s ability to provide a stable disease course and its favorable safety profile reinforce its position as a valuable treatment option for patients with this debilitating condition. The data from the ADVANCE-CIDP 3 study contribute significantly to our understanding of HyQvia’s role in managing CIDP and offer hope for extended maintenance therapy in patients battling this chronic disorder.