Shots:
- The CHMP has recommended approval of Xolremdi, under exceptional circumstances, for the treatment of WHIM syndrome, with EC’s decision expected in Q2’26
- Opinion was backed by the global P-III (4WHIM) trial assessing Xolremdi vs PBO in 31 pts (≥12yrs.) with WHIM syndrome, which showed improved absolute lymphocyte counts, absolute neutrophil counts, & fewer infections, plus Xolremdi significantly increased time above threshold for TAT-ANC & TAT-ALC
- Trial also showed benefit across composite endpoint, with ~40% reduction in total infection score as per infection severity, & 60% lower annualized infection rate, while total wart change scores showed no difference between arms over 52wks.
Ref: X4 Pharmaceuticals | Image: X4 Pharmaceuticals | Press Release
Related News: X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome
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