Hutchison China MediTech announced that the US Food and Drug Administration (FDA) has granted the Orphan Drug designation to surufatinib for the treatment of pancreatic neuroendocrine tumours (NETs). If approved, surufatinib will be entitled to seven years of market exclusivity for the approved indication. Additionally, Orphan Drug designation affords certain development cost benefits in the US.
Surufatinib is under investigation in multiple solid tumours in China and the US.
Christian Hogg, CEO of Chi-Med, said: “NET is an area of significant unmet medical need. The current treatment options are very limited. The FDA granting Orphan designation is a positive step and continues to reinforce the importance of our research and development in bringing surufatinib to more patients in need.”