SPEVIGO® Archives | Be Korea-savvy

CHMP Adopts Positive Opinion Recommending Approval of New and Expanded Indications for SPEVIGO®

The CHMP positive opinion is based on the EFFISAYIL® 2 trial, which showed that no flares were observed after week 4 of SPEVIGO® administered subcutaneously. During the 48-week trial, an 84% reduction of the risk of GPP flares was observed. GPP is a rare, chronic, heterogenous neutrophilic inflammatory disease associated with skin flares and systemic [...]

SPEVIGO® Approved for Expanded Indications in China and the US

Generalized pustular psoriasis (GPP) is a rare, chronic, heterogenous neutrophilic inflammatory disease associated with skin and systemic symptoms, such as fever, pain, and fatigue1,2,3,4 In China, SPEVIGO®’s expanded approval adds the reduction of occurrences of GPP in pediatric patients aged 12 and above weighing ≥40 kg, and adults5 The US FDA’s approval expands the use [...]