Grifols Doses First Patients in Two Phase 3 Trials to Expand Indications of its Flagship Immunoglobulins

Grifols announced the initiation of two Phase 3 clinical trials (SIGMA and XPERT) to expand U.S. label indications for its immunoglobulin therapies GAMUNEX-C and XEMBIFY. The SIGMA trial will evaluate GAMUNEX-C in secondary immunodeficiency patients with blood cancers, while XPERT will assess XEMBIFY's non-inferiority to GAMUNEX-C in CIDP patients. These trials aim to provide patients with more treatment options and support potential regulatory label expansions.