Orphan drug designation

August 2017

Dasiglucagon for the treatment of CHI

October 2017

Glepaglutide for the treatment of Short Bowel syndrome (SBS)


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