The P-III (ADVANCE-1) trial evaluating the efficacy, safety & tolerability of Hyqvia vs PBO in 132 adult patients with CIDP who had been on a stable dosing regimen of IV IVIG therapy for 3mos. before infusion
The trial met its 1EPs i.e., reduction in CIDP relapse (9.7% vs 31.4%) of neuromuscular disability & impairment as measured by INCAT when given at the same dose & dosing interval as the patient’s prior IVIG. The therapy showed a favorable safety profile thus supporting its use as maintenance therapy with no new safety risks
The (ADVANCE-3) trial & extension study will provide evidence for the safety profile for ~6yrs. The company is expected to submit applications for Hyqvia to regulatory authorities in the US & EU in 2022
Ref: Bussinesswire | Image: Takeda
