Sophia Graeff Buhl-Nielsen

Sophia Graeff Buhl-Nielsen asked if the phase III myositis readout would support approval by subgroup or largely depend on overall data, and how the commercial opportunities for IMNM and DM compare despite differences in addressable terms.

Answer

Karen Massey, COO, framed myositis as an MG-like opportunity. Luc Truyen, CMO, confirmed the phase III setup allows for statements on all three subsets, with regulatory discussions determining label reflection. Karen Massey, COO, explained IMNM (20,000 patients, no approved therapies) offers high patient capture due to clear biology, while DM (more patients, heterogeneous, more innovation) will require a strong value proposition to compete.

Sophia Graeff Buhl-Nielsen asked about the Phase 3 readout for VYVGART in myositis, specifically if data would support approval by subgroup or largely depend on overall data, and the commercial opportunities for IMNM versus DM given their differing addressable populations and heterogeneity.

Answer

Luc Truyen, Chief Medical Officer, confirmed the Phase 3 is designed to make statements on all three subsets, with regulatory discussions determining label reflection. Karen Massey, Chief Operating Officer, described the total myositis population as an MG-like opportunity. She noted that IMNM (20,000 patients, no approved therapies) presents a high patient capture opportunity due to clear biology, while DM (more patients, more heterogeneous, more innovation) will require a strong value proposition to compete effectively.