Positive top-line Phase IV results for Xembify
Barcelona, Spain-based plasma-derived medicine specialist Grifols (MCE: GRF) revealed that its recently concluded Phase IV trial (evaluating a biweekly dosing of Xembify has met its primary endpoint.
Xembify has demonstrated that patients with primary immunodeficiencies (PIDs) treated with this subcutaneous 20% immunoglobulin (SCIg) product every two weeks achieved non-inferiority in total Ig levels compared with those who received the medication weekly.
The Phase IV 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 US sites.
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