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X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome 

Shots: 

  • 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| Press Release

Related News:- Bausch + Lomb’s Lumify Receives the US FDA’s Approval to Treat Ocular Redness  

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