The US FDA has approved Xolremdi (mavorixafor) capsules for treating WHIM syndrome patients (12yrs. & above) and granted a Rare Pediatric Disease Priority Review Voucher to the company
The approval was supported by the P-III (4WHIM) study assessing the safety & efficacy of Xolremdi vs PBO to treat WHIM syndrome patients (n=31, 12yrs. & above)
The study depicted an increase in time above threshold for absolute neutrophil count (TAT-ANC) & absolute lymphocyte count (TAT-ALC), total infection score reduction by ~40% and an annualized infection rate reduction by 60% with no difference in total wart change scores over 52wks.
Ref: X4 Pharmaceuticals | Image: X4 Pharmaceuticals
Related News:- X4 Pharmaceuticals to Present P-III Trial (4WHIM) Results of Mavorixafor for the Treatment of WHIM Syndrome at CIS 2023
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