Passage Bio’s PBKR03 Receives EC’s Orphan Drug Designation for Krabbe Disease

April 6, 2021 Auto Bot EC, Orphan Drug Designation, receives, regulatory, Treatment 0

Shots:

  • The EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion
  • The designation provides potential benefits to the company, which include clinical protocol assistance, reduced regulatory fees, research grants, and up to 10 years of market exclusivity following regulatory approval
  • The company plans to initiate a P-I/II GALax-C trial for PBKR03 in H1’ 21. Additionally, PBKR03 previously has received FT, ODD, RPDD for the same treatment

Click here to­ read full press release/ article | Ref: Passage Bio | Image: The Pharma Letter

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