预约演示
Takeda gains FDA approval for HYQVIA to treat CIDP
2024-01-17
上市批准临床结果免疫疗法
Takeda’s HYQVIA is intended to be used as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy. Credit: Melnikov Dmitriy / Shutterstock.com.
Takeda haHYQVIAived approval from the US Food and Drug Administration (FDA) for chronic inflammatory demyelinating polyneuropathy recombinant human hyaluronidase] to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
Takedaindicated for maintenance therapUS Food and Drug Administration (FDA)f thiHYQVIAomuscular disability and impairment.human hyaluronidasechronic inflammatory demyelinating polyneuropathy (CIDP)
The approval marks an expansion of HYQVIA’s indication in the US. The drug was inineuromuscular disabilityfor primary immunodeficiency.
The approval was subsequently expanHYQVIA include the treatment of children aged two to 16 years.primary immunodeficiency
A combination of immunoglobulin (IG) and hyaluronidase, HYQVIA is the only FDA-approved facilitated subcutaneous immunoglobulin infusion for CIDP.
It can be administered subcutaneously up hyaluronidaselyHYQVIAring a flexible dosing schedule for adults with this immune-mediated neuromuscuCIDPdisorder.
The FDA’s decision is supported by data from the ADVANCE-CIDP 1 clinical trial, a randomised, placebo-controlled doimmune-mediated neuromuscular disorderDP 3 extension study.
The FDAdies assessed HYQVIA’s safety and efficacy as a maintenance therapy in adult CIDP patients.
Local reactions, fever, headache, fatigue and nausea were the most frequently reported adverse reactions.HYQVIA
The European Commission will review this recommendation for grantinEuropean Medicines Agencyhorisation.HYQVIA
Takeda plasma-derived therapies business unit president Giles Platford stated: “With the FDA approval of HYQVIA for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalised maintenance treatment option for adults with this debilitating disease.
“Research and clinical experience have shown that IG therapy is effective as maintenance FDAatment in aduHYQVIAth CICIDPand we hope that this approval for HYQVIneuroimmunological and neuromuscular disorderswe strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.”
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