EMA grants Rexgenero’s lead product REX-001 Advanced Therapy Medicinal Product Certificate for Manufacturing Quality and Non-Clinical Data
REX-001 is a novel cell therapy for the treatment of Critical Limb Ischemia (CLI), a disease which affects an estimated one million people in Europe
London, UK, 30th January 2018: Rexgenero Ltd, a clinical-stage regenerative medicine company developing advanced cell-based therapies with a focus on Critical Limb Ischemia (CLI), today announces that the European Medicines Agency (EMA) has granted Rexgenero an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data. The EMA certification paves the way for the Marketing Authorization Application (MAA) of its lead product REX-001, a novel cell therapy currently in a Phase III programme for the treatment of Critical Limb Ischemia (CLI).
Joe Dupere, Rexgenero’s CEO, commented, “We are delighted to have been granted an ATMP certificate for manufacturing quality and non-clinical data for REX-001. This is a major milestone for us as we work to bring this novel cell therapy to patients diagnosed with CLI, a disease with high unmet medical needs. We believe that REX-001 has the potential to be one of the first effective cell therapy products available for patients with CLI, a disease strongly associated with a high risk of amputation and mortality.”
Rexgenero received the certificate following a thorough scientific evaluation of the manufacturing quality data and non-clinical data by the EMA’s Committee for Advanced Therapies (CAT).