On 15/11/2021, orphan designation (EU/3/21/2521) was granted by the European Commission to MIMETECH S.r.l., Italy, for Udonitrectag as treatment in solid organ transplantation.
When organs are transplanted, the period in which they are cut off from their normal blood supply can lead to damage and death of cells that means they work less well after transplantation and are prone to inflammation that increases the risk of rejection. The medicine acts in the same way as natural growth factors that help to protect cells from this type of damage. This is expected to improve the function of the transplanted organ and reduce the risk of rejection.
At the time of submission of the application for orphan designation the effects of the medicine had been evaluated in experimental models and no clinical trials in patients undergoing solid organ transplantation had been started.