Grifols announces its Phase 4 trial of XEMBIFY met its primary endpoint

Grifols announced that its recently concluded phase 4 trial evaluating a biweekly dosing of XEMBIFY has met its primary endpoint. It has demonstrated that patients with primary immunodeficiencies treated with this subcutaneous 20% immunoglobulin product every two weeks achieved non-inferiority in total Ig levels compared with those who received the medication weekly. The phase 4 trial also demonstrated similarly good safety and tolerability profiles between biweekly and weekly administration. It was a multicenter, single-sequence, open-label clinical study that included 27 subjects across 18 U.S. sites. Results will support the potential product labeling extension of XEMBIFY to include biweekly dosing, pending review and approval by the United States Food and Drug Administration. This option is already available in the European markets where it is authorized.