Takeda has shared long-term results from a phase 3 study evaluating the safety and efficacy of HyQvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP).
HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) received regulatory approvals earlier this year to treat patients with the rare neurological disorder characterised by progressive weakness and reduced sensation in the arms and legs.
The therapy is the first and only facilitated subcutaneous immunoglobulin treatment for CIDP and can be self-administered after appropriate patient or caregiver training or given by a healthcare professional in a medical office, infusion centre or a patient’s home.
Results from the late-stage ADVANCE-CIDP 3 study demonstrated that HyQvia was well tolerated among the more than 3,400 infusions administered and the findings were consistent with the known safety and tolerability profile of the therapy, with no new safety concerns observed.
HyQvia was also shown to maintain a stable disease course and only 13% of those with data available experienced a relapse during the entire observation period, with an annualised relapse rate of 4.5%.
Kristina Allikmets, senior vice president and head of research and 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 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.”
HyQvia has been approved by the European Commission and the Medicines and Healthcare products Regulatory Agency as a maintenance therapy for CIDP patients of all ages following stabilisation with intravenous immunoglobulin therapy.
The treatment has also been granted approval by the US Food and Drug Administration as a maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults with CIDP.
ADVANCE-CIDP 3 presenting author, Robert Hadden, King’s College Hospital and King’s College London, said: “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 a facilitated subcutaneous immunoglobulin.”