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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post