NurExone Biologic announced that the EMA has granted orphan medicinal product designation to NurExone’s ExoPTEN intranasal exosome therapy, which the company is developing for the treatment of spinal cord injury. In 2023, the FDA granted orphan drug designation to ExoPTEN, and the company held a pre-IND meeting with the agency in anticipation of beginning clinical trials in 2025.
NurExone CEO Lior Shaltiel commented, “We are honored by the EMA’s recognition of ExoPTEN through the orphan medicinal product designation, which significantly advances our ability to enter the European market and offers hope to those impacted by acute spinal cord injuries. This designation, together with the recently granted United States Food and Drug Administration’s orphan drug designation, reinforces our ability to accelerate the global development of ExoPTEN and NurExone as a company to address the urgent unmet needs of patients globally.”
Head of CMC Quality and Regulation Ina Sarel said, “The EMA’s designation not only acknowledges ExoPTEN’s potential, but also paves the way for essential regulatory support as we prepare to advance into clinical trials. We are eager to work closely with the EMA and other agencies to accelerate ExoPTEN’s development and bring this innovative treatment to SCI patients across Europe.”
Read the NurExone press release.
