Approved as CIDP maintenance therapy… subcutaneous injection option provided
[의약뉴스] Takeda Pharmaceutical’s HyQvia has also acquired an indication for rare neuromuscular disorders in the United States.
Takeda announced on the 16th that the US Food and Drug Administration (FDA) has approved Hicubia as maintenance therapy to prevent recurrence of neuromuscular disorders and damage in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
▲ Takeda’s Hicubia has also been approved for subcutaneous administration as maintenance therapy for adult patients with chronic inflammatory demyelinating polyneuropathy.
Hicubia consists of 10% immunoglobulin (IG) and hyaluronidase for subcutaneous injection of immunoglobulin. Adult patients with CIDP can inject up to once a month (every 2, 3, or 4 weeks).
The ingredient hyaluronidase promotes the dispersion and absorption of large quantities of immunoglobulins in the subcutaneous space between the skin and muscles.
Hicubia can be administered by medical personnel in a clinic, infusion center or at the patient’s home and can be self-administered after adequate training of the patient and guardian.
In the United States, Hicubia was first approved as a treatment for primary immunodeficiency in adults in 2014, and was later expanded to include use in children aged 2 to 16 years.
This approval was based on results from ADVANCE-CIDP 1, a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Hicubia as a maintenance treatment for adult patients with CIDP, and ADVANCE-CIDP 3, a single-arm, open-label extension study.
The efficacy evaluation of ADVANCE-CIDP 1 included 122 adults with a confirmed diagnosis of CIDP who had received stable intravenous immunoglobulin (IVIG) for at least 3 months before testing.
The primary endpoint analysis showed that there was a statistically significant difference in the relapse rate between the Hicubia treatment group and the placebo group. The recurrence rate in the Hicubia group was 14% and in the placebo group was 32.3%, with a treatment difference of 18.3%, which demonstrates that Hicubia has a superior effect in preventing CIDP recurrence .
The safety of Hicubia in adult patients with CIDP was evaluated in the ADVANCE-CIDP 1 and ADVANCE-CIDP 3 studies. The most common adverse reactions observed in more than 5% of subjects were local reactions, headache, fever, nausea, fatigue, erythema, itching, increased lipase, abdominal pain, back pain and pain in the limbs.
Chronic inflammatory demyelinating polyneuropathy is a rare immune-mediated acquired neuromuscular disease affecting the peripheral nervous system. Progressive and symmetrical symptoms typically appear, such as weakness and numbness of the distal and proximal extremities, loss of sensation and reflexes, and gait disturbances.
Immunoglobulin treatment has an established role as maintenance therapy for CIDP and is a standard guideline-based treatment. However, intravenous injection of immunoglobulin can present problems such as a long treatment period associated with large amounts of immunoglobulin, difficulty in protecting a vein, and limitations in injection. environment.
“The approval of Hycubia for CIDP, which builds on our expertise in rare neuroimmune and neuromuscular diseases, allows us to provide tailored maintenance treatment options for adults with this debilitating disease,” said Giles Flatford, Head of Takeda’s plasma-derived therapeutics division. be,” he said.
He continued: “According to research and clinical experience, immunoglobulin treatment is effective as maintenance therapy for adult patients with CIDP. “We are committed to providing a broad and diverse portfolio of immunoglobulins to many patients with complex neuroimmune diseases, and we hope this approval will be the first of its kind globally.”
Takeda previously reported that in December last year, the Committee for Medicinal Products (CHMP) of the European Medicines Agency (EMA) recommended approval of Hycubia as maintenance therapy for adult patients with CIDP after stabilization with intravenous injection of immunoglobulins. The European Commission will consider the CHMP’s opinion and decide whether to grant final approval.
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