The US FDA Lifts the Clinical Hold of Protagonist’s Rusfertide Clinical Development Program

October 12, 2021 Auto Bot clinical hold, Clinical Trials, FDA 0

Shots:

  • The US FDA has lifted the clinical hold on the rusfertide development program & allow to resume patient dosing in clinical studies of rusfertide
  • The company provides the information to the FDA on the basis of complete response & also give patient clinical safety reports & update the investigator brochure, patient informed consent forms, safety database, and included new safety and stopping rules in the study protocols
  • The company plans to start P-III registrational study for polycythemia in Q1’22 & will continue to work with the FDA to ensure patient safety

Click here to­ read full press release/ article | Ref: Protagonist | Image: PR Newswire

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