Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation

Core Insights - The FDA has granted orphan drug designation to riliprubart for treating antibody-mediated rejection (AMR) in solid organ transplantation, highlighting a significant unmet need in transplant medicine [1][2] - Riliprubart is a first-in-class IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway [3] - Sanofi is conducting multiple clinical studies for riliprubart, including a phase 2 study for kidney transplant recipients and two phase 3 studies for chronic inflammatory demyelinating polyneuropathy [2][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging deep understanding of the immune system [5] - The company is committed to addressing urgent healthcare challenges and has a robust pipeline aimed at high unmet medical needs [5] Industry Context - Antibody-mediated rejection is a serious complication post-organ transplantation, where the recipient's immune system attacks the transplanted organ, leading to potential organ failure if untreated [4] - The orphan drug designation reflects the rarity of the condition, affecting fewer than 200,000 people in the US, and underscores the importance of developing targeted therapies in this area [1][4]