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Botanix Pharmaceuticals’ Sofdra (Sofpironium) Receives the US FDA’s Approval to Treat Primary Axillary Hyperhidrosis 

Shots: 

  • The US FDA has granted approval to Sofdra gel (12.45%) for the treatment of adults & children (≥9yrs.) with primary axillary hyperhidrosis 
  • The approval was based on the two pivotal P-III (CARDIGAN) trials assessing the efficacy & safety of Sofdra vs vehicle in primary axillary hyperhidrosis patients (n=701). Trials reached its 1EPs & 2EPs showing improved GSP & HDSM-AX7 score 
  • The patient experience program for the same is anticipated in Q3’24 with the introduction of Sofdra in Q4’24 

Ref: Botanix Pharmaceuticals | Image: Botanix Pharmaceuticals | Press Release

Related News:-  Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis  

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