Orphan drug designation

FDA

August 2017

Dasiglucagon for the treatment of CHI

October 2017

Glepaglutide for the treatment of Short Bowel syndrome (SBS)

 

EMA

June 2017

Multiple-dose formulation of dasiglucagon for the treatment of CHI


Orphan drug designation benefits

  • Potential for seven years of market exclusivity
  • Relief from user fees, e.g. PDUFA fee
  • Tax credits for clinical trial costs
  • Office of Orphan Products Development (OOPD) involvement